The state of the art facility will support the biopharmaceutical industry in Ireland by educating and training highly skilled staff and by conducting ground-breaking research in collaboration with industry. 

The new facility represents a major strategic investment in the bioprocessing industry in Ireland and is an innovative collaboration between four leading Higher Education Institutes – University College Dublin, Trinity College Dublin, Institute of Technology, Sligo and Dublin City University and supported by the Irish Government and IDA Ireland.

The NIBRT facility is unique as it is the only bioprocessing training facility in the world that so closely replicates an industrial bioprocessing environment. This allows trainees the opportunity to learn and practice complex technical bioprocessing procedures and to enhance their skills using the most modern equipment and facilities available anywhere.

Officiating at the opening, Minister Sherlock said:  “The pharmaceutical industry plays a critical role in the economic well-being of Ireland and the new NIBRT facility sets Ireland apart as a world class location for these companies”.  He added: “This is a far-sighted investment by the Government and IDA Ireland, to underpin the development of the pharmaceutical industry by supporting the collaboration with the founding Higher Education Institutes to establish NIBRT. Ireland will undoubtedly reap the benefits in the long run both in terms of high value job creation and in attracting further foreign direct investment from the industry to our shores”.

“This new facility will play a vital role in training personnel for the bioprocessing industry in Ireland”, said Mr. Joe Harford, Chairperson of NIBRT. “The availability of such excellent research facilities and highly skilled staff will also support IDA Ireland as it seeks to attract further biopharmaceutical companies to establish operations here. Our ability to successfully integrate ground-breaking research with world class training and education makes NIBRT globally unique”.

Professor Ian Marison, Interim Director of NIBRT, stated: “We are offering trainees and students an incredible learning experience. NIBRT will help to position Ireland as a global centre of excellence in bioprocessing. Our trainees will be the future leaders in an industry which plays such an important role in the Irish economy. Our aim is also to work with industry to identify the key issues affecting the biopharma industry today and to put together expert teams of scientists to solve these problems”.

CEO, IDA Ireland, Mr Barry O’Leary said: “Ireland has a long, successful track-record of attracting significant pharmaceutical investment from multinationals. We have now established Ireland as the second largest Development and Manufacturing (D&M) location in the world for Biopharmaceuticals, after the US. Global leaders in the Biopharmaceuticals  sector that have already undertaken significant investments in Ireland include Pfizer, Merck, Amgen, Genzyme (Sanofi), Lilly, Centocor (Johnson & Johnson), Allergan and Mylan. The establishment of NIBRT will further improve Ireland’s value proposition in attracting further Biopharmaceutical investment to Ireland.”

Ireland is a key location for the Life Sciences industry, with 9 of the top 10 global companies based here. The sector employs over 47,000 staff between indigenous and multinational companies in the areas of Pharmaceutical, Biotechnology, Medical Devices and Diagnostics. Exports last year were in excess of €46 billion - 42% of total exports from Ireland.

The 6,500 sq metres NIBRT facility is purpose-built to provide a world class training environment and was designed in conjunction with leading industry experts to resemble a modern bioprocessing plant.

The staff in NIBRT includes expert lecturers and trainers and world respected research teams headed by leading Principal Investigators (PIs). An example is Professor Pauline Rudd, who recently transferred her team from the Glycobiology Institute, Oxford University, to NIBRT. Professor Rudd is leading important research in the area of glycosylation changes which play a crucial role in the production of advanced biopharmaceuticals and which is also important in disease, particularly cancer and autoimmunity.

The first meeting of Glycoscience Ireland was a great success with over 150 participants from academic research organisations, biopharmaceutical and food industries in Ireland and overseas and representatives of the major funding agencies in Ireland. The 2nd and 3rd Annual meetings were equally successful. This year the meeting will be mainly focused on Food Glycobiology, and we are expecting our attendees to include representatives from the major Irish funding agencies, Irish academic institutions, Irish and multinational Food, Biopharmaceutical and Biotechnology industries, and a distinguished panel of speakers from the US and Europe.

Please note the following critical deadlines:

• August 22nd Registration opens
• August 22nd Acceptance of abstract submissions commences
• September 23rd Deadline for registration
• September 23rd Deadline for submission of abstracts

Call for abstracts

Abstracts should be identified under one of the following headings:

• Intestinal and Microbial Glycobiology

• Food Glycobiology

• Glycobiological methods

• Glycobiology in the food industry

A book of abstracts of all poster presentations will be available on the day. All submitted abstracts will go through a peer review process by the scientific committee.

Guidelines for abstract submission will be available on our website in the coming weeks. Authors will be informed regarding the acceptance of abstracts by September 30th 2011 via email.

From the 22nd of August, abstract submissions can be made by emailing :

glycoscienceireland2011[at]teagasc.ie

More information>>

The 4th GSI Meeting has attracted a number of key sponsors (AGRC, Teagasc, NIBRT, APC, SFI, EGSF, Eurofins Foods, Agilent, Mason Technology Ltd, Waters and Europa Bioproducts Ltd.) and exhibitors and has provided a unique platform for debate and discussion between academia and industry. The meeting was opened by Prof. Paul Ross, Director of Food Research in Teagasc and by Dr. Marion Boland of Science Foundation Ireland.

A presentation by Dr. Bernd Stahl, PhD Director Milk Research and Functional Innovations, Danone Center for Specialised Nutrition, Friedrichsdorf, Germany focused on breast milk as the source of a huge variety of health-promoting sugars. He and many other researchers are attempting to better understand the sugar composition in breast milk, in order to use this knowledge to develop food ingredients for infants. Continuing on this theme, Dr. Christoph Rohrig from Glycom, Denmark and Prof. David Newburg, Boston College, Chestnut Hill, US, also discussed the health benefits of human milk sugars and their principal components.

Dr Tony Corfield, University of Bristol, UK and Dr Marguerite Clyne, UCD in their respective presentations outlined how bacteria in the gut use sugars to talk to the gut mucosal cells and mucus. Such topics highlight that alimentary microbiology and glycosciences are each rapidly advancing research fields in their own right. However, together these two disciplines can provide a better understanding of both symbiotic and pathogenic relationships between hosts and bacteria in the gut. Prof. Paul Ross, also gave insight into how beneficial bacteria such as probiotics, can also produce sugars which allow them to survive better in the gastrointestinal tract. A topic also brought up by Dr. Lindsay Hall earlier in the day.

The fact that there has been increased interest in recent years on glycobiology related research, means that the identification of novel diagnostic markers, prophylactics, therapeutics and nutraceuticals for gastro-intestinal health may become a reality. Indeed, Prof. Eileen Treacy, UCD in her presentation on Galactosaemia exemplified such a scenario.

Teagasc have had recent success in attaining funding for glycobiology related research and are partners in the NUIG-led Alimentary Glycoscience Research Cluster (AGRC) which is funded by Science Foundation Ireland. Prof. Lokesh Joshi, Director of the AGRC and Prof. Pauline Rudd NIBRT both strongly support food glycobiology related research in Teagasc and chaired sessions on the day.

Dr. Rita Hickey, Chairperson of 4th Glycoscience Ireland meeting and fellow organiser Dr. Mariarosaria Marotta said: “We are pleased that this meeting has attracted such a high calibre of research scientists, from both academia and industry and highlights the international reputation of Teagasc Food Research Centre, the National University of Ireland, Galway, the National Institute for Bioprocessing Research & Training (NIBRT) and University College Cork in food and health related glycoscience research. It is imperative that this reputation is maintained through effective funding and resource management especially in the current economic climate where food and agriculture have been identified as significant growth areas of the Irish economy.”

The meeting is organised by Teagasc as part of the Alimentary Glycoscience Research Cluster (AGRC) in collaboration with NUIG, NIBRT and APC.

Further information:

http://www.glycoscienceireland.ie/conference.html

September 6-8, 2011

Dublin, Ireland

Fundamentals of Batch and Continuous Powder Processing:

Overview of solid dose and inhalable products. Design of sampling methods. Thief sampling. Thief errors. NIR spectroscopy and other PAT methods for blending. Blending fundamentals. Critical variables in blending. Types of equipment. Failure modes. Segregation, segregation testing. Design of the lubrication step. Blend over-lubrication. API agglomeration, causes and diagnosis. Failure modes. Characterization of powder flow properties and their effects on process and product performance.

QbD Methodologies for Batch and Continuous Processes:

Statistical methods for characterization of products and processes. Critical material properties: cohesion, density, hydrophobicity and electrostatics. Critical process parameters: shear, strain, compression force and speed. Effects on product quality attributes: dissolution, content uniformity, weight uniformity.

Continuous Manufacturing Technologies:

Regulatory issues. Design Fundamentals. API pre-conditioning. Feeders. Continuous mixers. API delumping and mixing. Continuous lubrication. Roller compaction. Continuous granulation. Tabletting. Capsule filling. Continuous coating. Equipment, critical variables. PAT approaches.

About Mixing Consultants, Inc.

Mixing Consultants, Inc. provides technical services, supporting research and development and technology transfer in all areas regarding characterization, design, optimization and control of mixing processes for powders, liquids and suspensions. Our focus are pharmaceutical, food, chemical and energy industries. Our mission is to support and educate industry in the application of technical knowledge and modern methods to achieve excellence in product and process design, manufacturing, scale-up, technology transfer and control.

Additional information and inquiries by e-mail to info@mixingconsultants.com or phone +1 (954) 727-3120.

Visit us at www.mixingconsultants.com

Further information>>

Agenda

Places are limited so register early to avoid disappointment!

We look forward to welcoming you!
Agilent Technologies
NIBRT 

NIBRT Certified Training

Introduction to Biopharma Sept 19-20

Upstream Processing: principles and practice Oct 17-19

Downstream Processing: principles and practice Oct 3-5

Fill Finish and Aseptic Processing Oct 24-27

Biopharma Analytical Techniques Nov 7-9

Training in association with Honeyman Group Limited

Sterilisation: Principles in Practice Sept 13-16

Applied Sterilisation Technology Sept 20-23

Microbiology for Non Microbiologists Sept 27-29

Water: Principles in Practice Oct 4-6

GAMP Oct 11-13

Environmental monitoring Oct 11-13

Applied Sterilisation Technology Oct 18-21

Professor Lichtenberg was speaking at the 18^th Annual Meeting of the Irish Pharmaceutical Healthcare Association (IPHA) at the Aviva Stadium which was titled Bringing the Best to Healthcare Through Partnership and Innovation.

One of a range of expert speakers from at home and abroad, Professor Lichtenberg told delegates that longevity increase is an important part of economic growth and development, which is in turn determined by  the rate of technological progress generated by private and public R+D investment. This is particularly evident in the pharmaceutical sector which is one of the most R+D intensive industries in the world. 

Professor Lichtenberg demonstrated that despite the high costs involved in developing new medicines, investment in innovation by the pharmaceutical industry is greatly increasing life expectancy, and is greatly reducing disability and hospitalisation. This is not, he argues, increasing per capita medical expenditure with the benefits of such innovation exceeding its cost by a substantial margin.

Delegates also heard from heard Professor Ian Marison, Chief Executive of the National Institute for Bioprocessing, Research and Training, and Dr. Graham Love, Director General of Science Foundation Ireland, on how innovation in the pharmaceutical industry in Ireland is being fostered and developed. They also heard Mr. Pat O’Mahony, Chief Executive of the Irish Medicines Board outline how regulatory structures can work to encourage innovation.

Earlier in the day, the meeting looked at Government plans to introduce a universal health insurance system here along the lines of the Dutch model. Mr. Michel Dutree, of Nefarma, which represents the pharmaceutical sector in the Netherlands, pointed to what he saw as real shortcomings in the system there which he claimed is completely cost driven, with only lip service to quality. Similarly, Dr. Steve Thomas of Trinity College, Dublin, acknowledging that the planned reform was a real opportunity, argued that this was dependent on the Government following the right and appropriate model for Ireland.

Mr. Kieran Ryan, Chief Executive of the Irish College of General Practitioners looked at the challenges the new system would bring to his members and argued in particular that it would require significant investment in primary care infrastructure.

Pictured at the IPHA Annual Meeting: Dr Graham Love (SFI), Minister Seán Sherlock TD, Bryan Dobson (RTE), Phillip Hannon (IPHA). 

Please contact us at any time to discuss your training requirements, or click here for further information on our training schedule.

The Continuing Education Programme in Brinny is part of MSD's commitment to supporting science education and research in Ireland as it takes a central role in the country's future as a knowledge-based economy.

John Howell, General Manager, MSD in Brinny said "Transformation is a key driver in securing the future of our business in Ireland and investing in the education of our employees is paramount to the success of this transformation process. At MSD in Brinny we continue to be committed to developing talent and enabling our people to enhance their skills so that we are in a position to attract further investment to Ireland. The support of Government to industry in these initiatives is key to the future success of the life sciences sector in Ireland".

The courses available include; a Higher Certificate in Science, a Bachelor of Science in Pharmaceutical Science, a Bachelor of Science in Biopharmaceutical Science and a Masters in Biopharmaceutical Science.

All of the courses, which are delivered primarily through online learning, have been designed to cater for the particular needs of adult learners and the programmes are designed, developed and delivered by a NIBRT/IT Sligo team of experienced trainers with a wide range of industry experience. MSD hope to register up to 60 people for the programme this year with the aim of starting another rotation in 2012.

IT Sligo’s Head of School of Science, Dr Jeremy Bird, said "IT Sligo’s online learning delivery method provides a platform which has the potential to be applied widely in industry. Our online courses provide such a degree of flexibility that it is possible for workers and students to take our courses from anywhere in the world. This flexibility is crucial in the workplace at the moment, because it provides companies and employees with the opportunity to update their skills without leaving the workplace, allowing them to maintain their competitiveness. Our close links with NIBRT enable us to jointly offer a programme of a high academic standard, while being very focused towards the industry’s educational requirements".

Prof Ian Marison, Director of NIBRT expressed the importance of such training programmes for the Irish pharmaceutical industry and how NIBRT can bring together important partners from across Ireland, including this one with IT Sligo, to provide tailored, fully accredited training programmes to suit industry’s needs now and in a developing, very competitive industrial environment. "MSD has taken a great initiative in providing their workforce with programmes which allow everyone, from operators to senior management, to develop their skills and careers. This plays a pivotal role in promoting the knowledge-based economy within Ireland. NIBRT fully supports this initiative and will work closely with MSD to achieve a high calibre programme which will benefit the company and enhance Ireland’s reputation as being at the forefront of the (bio)pharmaceutical industry" said Prof Marison.

The Continuing Education Programme is fully funded by MSD in conjunction with the IDA, so there is no financial cost to employees. The company plans to role out similar education initiatives in conjunction with NIBRT to employees at several of the other 7 MSD sites in Ireland in the coming months.

Notes to Editor 

Today's MSD is a global healthcare leader working to help the world be well. Following the completion of Merck & Co., Inc's merger with Schering-Plough Corporation the company is known as MSD worldwide, except in the United States and Canada where we are Merck. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.msd.ie.

MSD in Ireland

MSD employs 2,300 people directly in Ireland through its operations at sites in Carlow, Cork, Dublin, Tipperary and Wicklow.

In the last five decades the company has invested over €2.2bn in Ireland. MSD is one of Ireland's leading exporters and contributes significantly towards making the pharmaceutical industry the country's leading export sector. MSD is a member of Guaranteed Irish and manufactures or packages many of its leading products for the world market in Ireland.

IT Sligo

Institute of Technology, Sligo is the largest higher level education institution in the North West with more than 6,000 students and almost 600 staff. Its School of Science is the second largest in the Institute of Technology Sector, after Dublin Institute of Technology. IT Sligo is a recognised national leader in online education and has worked closely on staff training with a wide range of leading multinational companies such Coca Cola, Masonite International, Abbott Ireland and Baxter. Most recently it won the 'Best in eLearning' category in the 2011 Digital Media Awards. A team of students from IT Sligo took first place in the global final of the Microsoft Imagine Cup, the world's leading student technology competition, earlier this summer. For more information see www.itsligo.ie.

NIBRT

The National Institute for Bioprocessing Research and Training (NIBRT) is a global centre of excellence for training and research in bioprocessing. NIBRT is located in a new, world class facility in Dublin, Ireland. This facility is purpose built to closely replicate a modern bioprocessing plant with state of the art equipment.

NIBRT is based on an innovative collaboration between University College Dublin, Trinity College Dublin, Dublin City University and the Institute of Technology, Sligo. NIBRT was primarily funded by the Government of Ireland through Ireland's inward investment promotion agency, IDA Ireland (Industrial Development Agency), which is responsible for the attraction and development of foreign investment in Ireland. NIBRT offers a quality training and research experience not previously possible anywhere in the world.

Media Contacts

Sarah Connolly, Corporate Communications Manager, MSD

Tel. 01 299 8734 / 087 95 40430, E-mail: sarah.connolly@merck.com

Sinéad McGovern, Communication Manager, IT Sligo

Tel. 071 91 37348/ 087 6411725. Email: mcgovern.sinead@itsligo.ie

Killian O'Driscoll, NIBRT Director of Projects.

Tel. + 353 1 215 8107, Email: killian.odriscoll@nibrt.ie

Founded by the Irish Government and the University College Dublin, the Trinity College Dublin, the Dublin City University and the Institute of Technology in Sligo, NIBRT is to become a global center of excellence for training and research in bioprocessing. The Dublin-based facility simulates a modern bioprocessing plant with state-of-the-art equipment.

Successful collaboration
Endress+Hauser has also contributed to the success of NIBRT: In November the ‘People for Process Automation’ installed a tailor-made training unit for employees from the life sciences industry.

On Monday 28 November, after two years of intense collaboration, Endress+Hauser and NIBRT will reinforced their partnership by signing the contract in Reinach, Switzerland. “This collaboration will enable us to provide world leading training programs on measurement instrumentation for the life sciences industry,” states Professor Ian Marison, CEO of NIBRT. Michael Ziesemer, COO of the Endress+Hauser Group, adds: “The foundation of NIBRT is an important milestone for the Irish biotechnological and life sciences sector – we are proud to partner with NIBRT. We look forward supporting NIBRT in the future in order to generate innovations in this important industry.”

Experiencing (almost) real processes
The training unit simulates biotechnological production and cleaning processes. Trainees not only experience practically how to configure, calibrate and maintain field instrumentation, but also how to use different communication protocols, Plan Asset Management tools and the control platform produced by Rockwell Automation. They are trained under realistic conditions while being allowed to make mistakes and learn from them, without affecting real production.

“We are pleased that, with our support, NIBRT has been able to enhance its training program with a module for process instrumentation and control,” says Christophe Roche, General Manager of Endress+Hauser Ireland, who supported the project. “This collaboration continues the idea of our company founder Georg H Endress to establish partnerships with universities and educational institutes.”

Bundled know how
The training unit has been developed and built at Endress+Hauser in Reinach, in close collaboration with NIBRT and Rockwell Automation. “We have had a strategic alliance with Endress+Hauser since 2007. Our combined strengths bring increased value to customers in process industries by reducing the engineering associated with field device integration and simplifying asset management,” says Mark Bottomley, Country Manager - Ireland at Rockwell Automation. “We are pleased to be associated with the NIBRT facility which we see as a major benefit in supporting and further promoting the life sciences industry in Ireland.” 

Endress+Hauser (Ireland) Ltd.
Established in 1979 as a representative in Clane Co. Kildare Endress+Hauser Ireland has quickly expanded into fully fledged subsidiary for the Irish Market. A dedicated and highly experienced team of 22 employees serve customers from the life sciences, food & beverage, environmental and primaries industries at every stage.

NIBRT
The National Institute for Bioprocessing Research and Training (NIBRT) is a global center of excellence for training and research in bioprocessing. NIBRT is located in a new, world class facility in Dublin, Ireland. This facility is purpose built to closely replicate a modern bioprocessing plant with state-of-the-art equipment.

NIBRT is based on an innovative collaboration between University College Dublin, Trinity College Dublin, Dublin City University and the Institute of Technology, Sligo. NIBRT was primarily funded by the Government of Ireland through Ireland’s inward investment promotion agency, IDA Ireland (Industrial Development Agency), which is responsible for the attraction and development of foreign investment in Ireland. NIBRT offers a quality training and research experience not previously possible anywhere in the world.

The Endress+Hauser Group
Endress+Hauser is a global leader in measurement instrumentation, services and solutions for industrial process engineering. In 2010, the Group generated with over 8,500 employees worldwide net sales of around 1.3 billion euros.

Structure
Company-owned sales centers and a network of partners guarantee competent worldwide support. Production centers in eleven countries meet customers’ needs and requirements quickly and effectively. As a successful family-owned business, Endress+Hauser is set for continued independence and self-reliance in the future.

Products
Endress+Hauser provides sensors, instruments, systems and services for level, flow, pressure and temperature measurement as well as liquid analysis and data acquisition. The company supports customers with solutions and services in automation engineering, logistics and information technology. Our products set standards in quality and technology.

Industries
Customers are primarily from the chemical/petrochemical, food & beverage, water/wastewater, life science, oil & gas, power & energy, renewable energies, primaries & metal, pulp & paper and shipbuilding industries. Endress+ Hauser supports its customers to optimize their process engineering procedures while taking into consideration reliability, safety, economic efficiency and environmental protection.

History
Founded in 1953 by Georg H Endress (1924 – 2008) and Ludwig Hauser (1895 – 1975), Endress+Hauser has been solely owned by the Endress family since 1975. The company group, headed by Klaus Endress since 1995, has developed from being a specialist in level measurement to a provider of complete solutions for industrial measuring technology and automation, with constant expansion into new territories and markets.

For further information, please visit www.endress.com or www.press.endress.com

Contact Endress+Hauser

Christophe Roche                                                                    Email : christophe.roche@ie.endress.com
General Manager                                                                     Phone  +353 45 98 9202
Endress+Hauser (Ireland) Ltd.                                              Fax       +353 45 86 8182
Clane Business Park
Clane / Co. Kildare
Ireland

Contact NIBRT
Killian O’Driscoll                                                                      Email : killian.odriscoll@nibrt.ie
Director of Projects                                                                  Phone     + 353 1 207 8107
NIBRT,
Foster Avenue,
Mount Merrion,
Blackrock 
Co. Dublin,
Ireland.

Note:
For information on the "Instrumentation and Control" training programme please refer to the following link.

The following speakers will present at the seminar:

• Conor Anderson, Director, Analytiqa: ‘A Short Guide to AEO (Authorised Economic Operator)’

• Mark Greene, Director, Brentech Data Systems Ltd: ‘Secure high volume medicines distribution with FULL traceability’

• Dermot O’Leary, Chief Economist, Goodbody Stockbrokers: ‘Economic Outlook – Stability in a Fragile World’

• Jim Bracken, Chief Executive Officer, GS1 Ireland: ‘An Update on Regulatory Requirements for Medicines and Devices and an Insight in to Product Master Data Management’

• Ciarán Brady, Managing Director, PLS Pharma Logistics: ‘An Overview of the Key Changes to the New Consultative Guide on Good Distribution Practice’

The presentations will finish at 5:00pm and will be followed by an optional tour of NIBRT and a networking reception.

RSVP to fionaluciani@irishexporters.ie or by calling 01 6612183 before Monday, November 21, 2011.

Venue: NIBRT, Foster Avenue, Mount Merrion, Co. Dublin.

Date: Thursday, November 24, 2011

Time: 2:00pm – 5:30pm

Cost: Free for IEA members.€50 for non-IEA members.

Understanding protein glycosylation, glycan linkage and composition is important throughout the development of a biopharmaceutical as it can potentially affect bioactivity, safety and efficacy of the final product. The market for glycoprotein medicines is forecasted to grow significantly in near future.

The collaboration advances Intertek’s existing suite of characterisation services for recombinant proteins, biosimilars and monoclonal antibodies. These services, available as regulatory work packages, include strategic structural characterisation, physico-chemical property determination according to ICH Q6B Guidelines, comparability studies and more.

Andrew Swift, EVP of Intertek's Chemical & Pharmaceutical services said “Our collaboration with NIBRT increases the depth of characterisation support services to the biopharma industry and creates an unparalleled virtual team who can deliver advanced analytical support to our clients.”

Intertek Biotechnology Team Leader, Ashleigh Wake added “NIBRT’s expertise in glycan characterisation complements our existing glycoprotein analysis capabilities and will enable us to provide comprehensive analytics for monoclonal antibody therapeutics in particular.”

Professor Pauline Rudd added “We have recently brought together our suite of Glycoanalytical technologies in the new purpose built NIBRT facility. Glycosylation analysis remains a major challenge, especially in the production of biologicals and we are delighted to support the pharmaceutical communities by launching this new enterprise with Intertek. NIBRT is at the cutting edge of the field. We approach the complexity of glycosylation analysis using orthogonal technologies, including state of the art quantitative, UHPLC separations coupled with specific exoglycosidase digestions, CE and mass spectrometry.“

About Intertek www.Intertek.com

Intertek Group Plc (FTSE: ITRK) is a leading international provider of quality and safety services to a wide range of global and local industries. Intertek help to ensure that client’s products and processes meet industry standards and consumer expectations for safety and quality in virtually any market. Intertek Pharmaceutical Services provide GxP analytical and bioanalytical services supporting the critical stages of R&D, authorization and manufacturing for pharmaceuticals and biopharmaceuticals. Our services cover every aspect of product development, operational and manufacturing process, marketing, supply chain management, safety, quality and sustainability.

Contact:

Lorna Kettle, Business Development Strategy Manager, Intertek Pharmaceutical Services, Tel: +44 (0) 161 721 1476, lorna.kettle@intertek.com

About NIBRT www.nibrt.ie

NIBRT is a world-class institute that provides training and research solutions for the bioprocessing industry. Our mission is to support the bioprocessing industry by providing a unique learning experience for trainees in an environment that replicates the most modern industrial bioprocessing facility. In parallel, we also undertake leading edge research in key areas of bioprocessing in collaboration with industry.

Contact:

Killian O’Driscoll, NIBRT Director of Projects. Tel: + 353 1 215 8100 killian.odriscoll@nibrt.ie

NIBRT, Foster Avenue, Mount Merrion, Blackrock, Co.Dublin.

The presentations will be delivered by experts in their field; Ashleigh Wake Intertek’s Biotechnology Team Leader and Professor Pauline Rudd, a leading authority on protein glycosylation.

This seminar would be of interest to professionals working in protein therapeutic development and manufacturing.

Agenda:

• Introduction to the Intertek / NIBRT strategic collaboration

• A Strategic approach to glycoprotein analysis – Ashleigh Wake, Intertek Biotechnology Team Leader

• A systematic approach to protein glycosylation analysis – Prof. Pauline Rudd, NIBRT

Dates:

• 22nd September 2011, Intertek, Manchester, UK
• 23rd September 2011, NIBRT, Dublin, Ireland

The National Institute for Bioprocessing Research and Training is a world-class institute providing training and research solutions for the bioprocessing industry in state-of-the-art facilities

Thursday 13th October 2011

Registration 11:00 a.m.

Morning

NIBRT Plant Tour 11 a.m. – 1 p.m. 

Afternoon

ISPE Student Event

Poster Competition

Student Networking with industry professionals

(Lunch provided for those staying for networking session)

Event will finish at 3 p.m.

Cost: This event is free for Members and all Students, €80 per person for non-members.

Vendor Table Tops (allowing companies to promote their career opportunities to students) €250.

Payment must be made in advance. Cash or cheques payable to “ISPE Ireland”

No credit cards. Receipts will be issued on request.

Registration forms, available on the ISPE Ireland website, should be completed and returned no later than 1:00 p.m. Friday 07th October 2011

Location: The  National Institute for Bioprocessing Research and Training (NIBRT)
February 28, 2012: 09:00 am to 14:30 

Preliminary Agenda:

• Scientific Presentation By NIBRT 
• The Business Benefits of QbD: Results of an International Survey carried out by our CoP
• The newly released document from ICH on points to consider for modelling and its implications on PAT models and Real Time Release Models
• Report on the Regulatory Workshop at IFPAC (Jan 2012) on NIR (Path toward RTR testing: NIR implementation in pharmaceutical and biopharmaceutical manufacturing. Technical and Regulatory Perspectives
• Tour of NIBRT facilities
• Presentation by member company on PAT application
     

To register please contact us.

We are looking forward to see you.
 
Best Regards           
The UK & Ireland ISPE PAT CoP Committee.

Allergan Pharmaceuticals Ireland is currently offering two positions within the organisation:

• Analytical Scientist, Biologics Development
• Formulation Scientist, Biologics Development

Merck is looking to fill the following two vacancies:

• Supervisor Bioassay CoE 
• Principal Scientist within Tech Services

View further details of each of the positions listed >>

The goal of the collaboration is to develop new, robust and reproducible biochemical assays for the analysis of the biological activity of therapeutic monoclonal antibodies. Current industry-standard techniques for research and manufacture often rely on cell-based assays, which can be non-quantitative, labour intensive and highly variable. The collaboration will combine NIBRT's leading expertise in in glycobiology and novel bioanalytical techniques with GE Healthcare's capabilities in protein-protein interaction analysis, particularly the company's Biacore™ SPR technology.

Welcoming the collaboration, Professor Ian Marison, NIBRT Interim Director said: "We are delighted with this research collaboration with GE Healthcare, which will allow NIBRT to apply its bioanalytical expertise to develop novel analytical platforms for the determination of monoclonal antibody biological activity. We look forward to working with GE Healthcare on this exciting project and developing our relationship further over time".

The research will be led by NIBRT's Principal Investigator and global leader in glycobiology, Professor Pauline Rudd, in conjunction with researchers from GE Healthcare Life Sciences laboratories in Uppsala, Sweden.

Dr. Lotta Ljungqvist, Head of Research and Development for the BioTechnologies business of GE Healthcare Life Sciences said, "Our goal is to help our customers optimize every step of their discovery, development and biopharmaceutical manufacturing process, and so help reduce cost of entry, deliver higher yields of finished product and reduce time to market. This collaboration will help us to drive the development of new, biologically relevant and fully characterized binding assays for measuring antibody activity, a critical step in the design and manufacture of effective monoclonal antibody based therapies. We look forward to a productive collaboration with the talented team at NIBRT.

Notes to Editor

 About NIBRT

The National Institute for Bioprocessing Research and Training (NIBRT) is a global centre of excellence for training and research in bioprocessing. NIBRT is located in a new, world class facility in Dublin, Ireland. This facility is purpose built to closely replicate a modern bioprocessing plant with state of the art equipment.

NIBRT is based on an innovative collaboration between University College Dublin, Trinity College Dublin, Dublin City University and the Institute of Technology, Sligo. NIBRT was primarily funded by the Government of Ireland through Ireland's inward investment promotion agency, IDA Ireland (Industrial Development Agency), which is responsible for the attraction and development of foreign investment in Ireland. NIBRT offers a quality training and research experience not previously possible anywhere in the world.

Media contact:
Killian O'Driscoll killian.odriscoll@nibrt.ie
+ 353 1 215 8107 www.nibrt.ie

About GE Healthcare

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems.

Our "healthymagination" vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality around the world. Headquartered in the United Kingdom, GE Healthcare is a unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employees are committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.

For our latest news, please visit http://newsroom.gehealthcare.com

• National Institute for Bioprocessing Research and Training (NIBRT), winner of the Facility of the Year Award Special Recognition for Novel Collaboration for its New Greenfield facility in Dublin, Ireland
• Chiesi Farmaceutici S.p.A., winner of the Facility of the Year Award for Sustainability for its Chiesi Farmaceutici Research and Development Centre facility in Parma, Italy
• Eisai Pharmatechnology & Manufacturing Pvt. Ltd., winner of the Facility of the Year Award for Project Execution for its Eisai Knowledge Centre facility in Visakhapatnam, Andhra Pradesh India
• Merck & Co., Inc., winner of the Facility of the Year Award for Facility Integration for its Merck Vaccine Bulk Manufacturing Facility (VBF) Program of Projects in Durham, North Carolina USA
• Rentschler Biotechnologie GmbH, winner of the Facility of the Year Award for Equipment Innovation for its REX III manufacturing facility in Laupheim, Germany
• Roche Diagnostics GmbH, winner of the Facility of the Year Award for Operational Excellence for its TP Expand project in Penzberg, Germany

The FOYA program is the pharmaceutical industry’s premier awards program dedicated to celebrating innovation and accomplishments in facility design, construction, and operation. The Facility of the Year Awards program recognizes state-of-the-art pharmaceutical manufacturing projects that utilize new and innovative technologies to enhance the delivery of a quality project, as well as reduce the cost of producing high-quality medicines. Now entering its ninth year, the awards program effectively spotlights the accomplishments, shared commitment, and dedication of individuals in companies worldwide to innovate and advance pharmaceutical manufacturing technology for the benefit of patients worldwide. The Facility of the Year Awards program is sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine.

“Our 2012 Category Winners reflect the true spirit of the Facility of the Year Awards program,” said Judging Panel Chairperson Chaz Calitri. “The winning projects exemplify innovation in pharmaceutical manufacturing for the benefit of patients all over the world, who depend upon us for medications that are high quality, available and affordable. Our winners come from 5 different countries and include novel, low cost biologics facilities, creative and visionary industry-academia-government collaborations, and hyper-fast track investments made to ensure vaccine’s get to patients in need. We are also proud this year to recognize facilities that seek to speed up drug development as well as facilities that greatly reduce the environmental “footprint” of manufacturing in the communities in which they reside”

Killian O’Driscoll, NIBRT Director of Projects thanked the Judging Panel for their award and commented “We are delighted to receive this award on behalf of all those who contributed to the successful NIBRT project. We now look forward to continuing to support the training and research needs of the (bio)pharma industry in our state-of-the-art facility.”

The Facility of the Year Awards program is truly global, as submissions over the past eight years have been received from more than 25 different countries and territories. Each of the submissions was reviewed by an independent, blue-ribbon judging panel consisting of global senior-level executives from all aspects of the industry. The judging panel met personally in December to select the Category Awards Winners and select the 2012 overall winner, which will be announced to the world for the first time at ISPE’s Annual Meeting in November.

2012 Facility of the Year Events
There will be several opportunities to learn first-hand about the facilities being honored as “best in their class.” These opportunities include: 

• INTERPHEX2012 – Attendees will be able to meet the Category Award Winners at the Facility of the Year Awards Display Area near the front of the exhibit hall of the Jacob K. Javits Convention Center in New York City, New York, USA. Team members from winning companies will be on-hand to discuss the success stories associated with these pharmaceutical manufacturing facilities. More information, including registration information, can be found at www.interphex.com.
• ISPE 2012 Annual Meeting – Category Winners will give presentations about their winning projects during ISPE’s 2012 Annual Meeting, 11-14 November in San Francisco, California USA. The highly anticipated announcement of the 2012 Facility of the Year Awards Overall Winner will also take place during the Keynote Session of this event. Information and updates on this global event can be found at www.ISPE.org.
• Feature Articles – Comprehensive coverage will appear in Pharmaceutical Processing magazine and ISPE’s Pharmaceutical Engineering magazine.

Comprehensive details about each of this year’s award-winning projects and their support teams, plus additional information on the awards program itself, can be found at www.FacilityoftheYear.org.

About NIBRT

The National Institute for Bioprocessing Research and Training (NIBRT) is a global centre of excellence for training and research in bioprocessing. NIBRT is located in a new, world class facility in Dublin, Ireland. Further information is available from www.nibrt.ie

Killian O’Driscoll
NIBRT Director of Projects
killian.odriscoll@nibrt.ie
+ 353 1 215 8100

About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is a not-for-profit Society of 22,000 pharmaceutical professionals in 90 countries who use expert knowledge to create high-quality, cost-effective GMP solutions. ISPE is “Connecting a World of Pharmaceutical Knowledge” by providing Members with opportunities to develop their technical knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning opportunities for a global audience and has its worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; an Asia Pacific office in Singapore; and its newest office in Shanghai, China. Visit www.ISPE.org for additional Society news and information.

About INTERPHEX
Now in its 33rd year, INTERPHEX is the largest gathering for FDA regulated drug and drug delivery products for technical professionals in development & manufacturing for pharmaceutical, biologic, generic, contract manufacturing and supporting services. ISPE is the exclusive official association sponsor of this industry-leading annual event. Scheduled for May 1-3, 2012 at the Javits Convention Center in New York City, NY, USA, the event hosts more than 650 suppliers on the show floor along with an expanded conference program, featuring a high-profile roster of subject matter experts. For information, visit www.INTERPHEX.com/ISPE.

About Pharmaceutical Processing
Pharmaceutical Processing magazine is the pharmaceutical industry's leading information provider, reporting on a full range of innovative new products, equipment, technology and trends for 28,000 engineers and managers responsible for the development, manufacture, validation and packaging of pharmaceuticals. An official sponsor of INTERPHEX, Pharmaceutical Processing distributes critical information to these professionals in a timely manner through a full range of print, electronic and online media. For information, visit www.pharmpro.com. 

In April 2010, The Honeyman Group announced the opening of Honeyman Ireland, additional offices and laboratories in Dublin to provide a platform for the company to serve its long-standing Irish based clients. In February, Honeyman Ireland was inspected by the Irish Medicines Board (IMB) and subsequently approved as a GMP compliant contract analytical laboratory.

Mark Thompson, Managing Director of The Honeyman Group, said: “This new partnership with NIBRT takes us to a new level.  By teaming up with NIBRT we will be able to deliver our internationally recognised courses in a world class simulated GMP pharmaceutical manufacturing facility, this is a fantastic development for the industry as I believe that no other training provider in Europe can offer this level of technical training backed up with such engaging facilities”

Ian Nelligan, Training Director at NIBRT said, “We are delighted to partner with the Honeyman Group for the delivery of their training portfolio. This excellent training will be delivered in a facility that is purpose built to the highest global standards. This will give delegates a learning experience that is unsurpassed anywhere in the world”.

Ian joins NIBRT from Dublin City University. Formerly, Professor in Bioprocess Engineering at the University of Western Switzerland and Senior Scientist at the École Polytechnique Fédérale de Lausanne in Switzerland, Ian joined DCU in 2005 as Head of School of Biotechnology and holds the Chair in Bioprocess Engineering. Throughout his career, Ian has worked with top global pharmaceutical companies managing large scale research projects and providing bespoke training courses. As a result, he has built an excellent international reputation as an effective scientist (with 169 journal articles), administrator and leader.

As co-founder of three companies, including Inotech Bioencapsulation AG in Switzerland, Ian has more than 20 years experience in senior management within research, academic and industrial fields.

As Interim Director, and working with the IDA, Ian will be actively promoting NIBRT internationally as a world-class institute that provides training, educational and research solutions for the Irish and international bioprocessing industry and to support the growth and development of the Irish industry.

Minister Bruton will be given a short tour of our state of the art facility including our processing plant, laboratories and training rooms. He will unveil a plaque which has been specially designed to mark the occasion and he will give a key note address to our invited guests. Our audience will also be addressed by our Chairman, Mr Joe Harford and by our new Interim Director, Professor Ian Marison. A panel discussion on future skills requirements for the industry will take place followed by an informal lunch. Guests will then have the opportunity to tour the facility. We anticipate an interesting and informative day.   

Special Purpose Award: Aseptic Processing
This is a comprehensive, practical course based on current aseptic techniques related to working in a cleanroom and isolator environment.
For further information please click here.

Special Purpose Award: Biopharma Operations
This is a comprehensive, practical course based on current GMP best practice which has been designed in partnership with Industry  for staff working in upstream and downstream bioprocessing.
For further information please click here.

The event kicked off a new educational series from Pall Corporation (NYSE:PLL) designed to encourage collaboration and best practices among the global community of single-use system users. The next installment in the series is scheduled for Thursday, November 3, 2011 near Swindon in Wiltshire, England.

“As the bioprocessing industry rapidly shifts towards a single-use manufacturing paradigm, the need for sharing experiences and establishing global best practice becomes ever more important,” said Yves Baratelli, president, Pall Life Sciences. “The Pall Master Class series provides an educational forum for biopharmaceutical professionals who are involved with, or are considering, the implementation of single-use manufacturing solutions.”

More than 50 delegates from across Europe, including emerging markets such as Hungary and Romania, attended the inaugural master class. The class was held at NIBRT’s state-of-the-art training and research facility, which was designed to support the deployment of advanced technologies such as single-use manufacturing solutions.

Presentations covered the qualification and validation of single-use systems with an emphasis on the study and measurement of extractables, leachables, particulates, and endotoxins. Insight on a range of case studies was provided by leading authorities in the areas of chemistry and biochemistry. These included Weibing Ding, Ph.D. (chemistry), and Hélène Pora, Ph.D. (biochemistry), from Pall Life Sciences; chemical engineers Peter Rogge and Benjamin Minow from Rentschler Biotech, Germany; and pharmacist Jean-Pascal Zambaux from Disposable-Lab, France. Roundtable discussions focused on the requirements for process specific validation, the challenges of automation and the supplier/end-user relationship.

Topics for the next master class include the following: sterilization by irradiation-processing technology; single-use systems in the contract manufacturing environment; applications within a small- to medium-sized biotechnology company; sterile formulation and filling applications; and academic research and training on single-use systems. There also will be a presentation on regulatory issues entitled: “At inspection, biopharmaceuticals are often not such a special case after all!”

For more details about upcoming master class sessions, contact sumasterclass@pall.com.

Register for the November 3 session at ukmasterclass@pall.com.

About Pall Life Sciences

Pall Life Sciences provides cutting-edge products and services to meet the demanding needs of customers discovering, developing and producing biotech drugs, vaccines and classic pharmaceuticals. Pall technologies are also used to collect and process blood components and help protect patients from hospital-acquired infections. The company’s membranes and membrane devices optimize detection and sample preparation in the drug research, clinical diagnostics, genomics, and proteomics markets. Pall is a leading provider of separation systems and single-use filtration and purification technologies to pharmaceutical and biotechnology companies to support faster development of new drugs and vaccines that are safer and require less energy and water to produce.

About Pall Corporation

Pall Corporation (NYSE:PLL) is a filtration, separation and purification leader providing solutions to meet the critical fluid management needs of customers across the broad spectrum of life sciences and industry. Pall works with customers to advance health, safety and environmentally responsible technologies. The Company’s engineered products enable process and product innovation and minimize emissions and waste. Pall Corporation, with total revenues of $2.7 billion for fiscal year 2011, is an S&P 500 company with almost 11,000 employees serving customers worldwide. Pall has been named a “top green company” by Newsweek magazine. To see how Pall is helping enable a greener, safer, more sustainable future, follow us on Twitter @PallCorporation or visit www.pall.com/green.

About NIBRT

The National Institute for Bioprocessing Research and Training (NIBRT) is a global center of excellence for training and research in bioprocessing. NIBRT is located in a new, world class facility in Dublin, Ireland. This facility is purpose built to closely replicate a modern bioprocessing plant with state-of-the-art equipment.

NIBRT is based on an innovative collaboration between University College Dublin, Trinity College Dublin, Dublin City University and the Institute of Technology, Sligo. NIBRT was primarily funded by the Government of Ireland through Ireland’s inward investment promotion agency, IDA Ireland (Industrial Development Agency), which is responsible for the attraction and development of foreign investment in Ireland. NIBRT offers a quality training and research experience not previously possible anywhere in the world.

Contacts:

Doug Novarro
Pall Corporation
Corporate Public Relations
+15168019944
doug_novarro@pall.com
Follow us on Twitter @pallcorporation

Killian O’Driscoll
NIBRT
+ 353 1 207 8107
killian.odriscoll@nibrt.ie

SANTA CLARA, Calif. and DUBLIN, Ireland, June 29, 2010 -- Agilent Technologies Inc. (NYSE: A) and the Agilent Foundation today announced that Professor Pauline Rudd has received an Agilent Thought Leader Award in support of her emerging glycomics research.

The award includes a grant of funding and instruments to the National Institute for Bioprocessing Research and Training (NIBRT) in Dublin, Ireland. The goals of the research are to develop novel approaches to analyze protein glycosylation which will assist in the characterization of recombinant protein drugs, and to study potential glycan biomarkers associated with disease using liquid chromatography/mass spectrometry.

As leading experts in glycomics research, Professor Rudd’s group members have developed a new technology for high-throughput, detailed, quantitative glycan analysis at NIBRT’s Glycobiology Group Laboratory.

“Our partnership with Agilent will focus on multidimensional nanoscale LC-MS/MS separations for the comprehensive analysis of released oligosaccharides,” said Maurice N. Treacy, CEO of NIRBT. “The research will leverage the expertise of Agilent in separation sciences and NIBRT’s expertise in glycobiology to allow the development of novel technologies and complete solutions for rapid glycan analysis for use by the bio-pharmaceutical sector and in academia.”

The NIBRT Glycobiology Lab is at the forefront of fully automating technologies for glycan release and labelling, HPLC analysis, and exoglycosidase sequencing. Dedicated software and experimental databases enable computer assisted data analysis. The platform is allied to MS technologies to obtain further structural characterization and to provide a service that supports the drug development pipeline of leading pharmaceutical companies.

“Agilent is uniquely positioned to provide comprehensive analytical solutions for glycoprotein characterization and oligosaccharide analysis,” said Gustavo Salem, vice president and general manager of the Biological Systems Division at Agilent. “We are very eager to begin working with leading glycomics scientists at NIBRT to continue to drive research and discovery in this emerging field.”

Rudi Grimm, Ph.D., director of science and technology for Agilent’s Life Science Group, will work closely with Professor Rudd to provide technical expertise and serving as the primary contact with Agilent. Dr. Grimm created the opportunity for the grant by working with Agilent’s University Relations Program and Life Sciences Group to secure funding and instrumentation.

This is the first award from Agilent’s new Thought Leader Program, which promotes fundamental advances in the life sciences by contributing financial support, products and/or expertise to the research of influential thought leaders.

About National Institute for Bioprocessing Research and Training (NIBRT)

NIBRT - National Institute for Bioprocessing Research and Training, Dublin: Ireland is a centre of excellence that supports the biopharma sector by offering research platform solutions for bio-manufacturing, provides tailored accredited industrial training and academic educational programmes to students in purposebuilt flexible and modern bioprocessing facilities, that will facilitate the expansion of the bio-pharma sector in Ireland. For further information please refer to www.nibrt.ie.

About Agilent Foundation: The Agilent Technologies Foundation funds university research at the frontiers of measurement in electronics, chemical and bio sciences. It also supports initiatives that advance science education in Agilent communities around the world.

About Agilent Technologies: Agilent Technologies Inc. (NYSE: A) is the world’s premier measurement company and a technology leader in chemical analysis, life sciences, electronics and communications. The company’s 19,000 employees serve customers in more than 110 countries. Agilent had net revenues of $4.5 billion in fiscal 2009. Information about Agilent is available on the Web at www.agilent.com.

This 5 month training / education programme will prepare candidates for a diverse range of roles in the biopharmaceutical and healthcare sector. The course will consist of a combination of classroom and practical laboratory activities. The classroom modules will be delivered in an accessible location adjacent to ITT Dublin and the Laboratory practical’s will take place in the NIBRT facility.

The course consists of a series of scientific, technological, regulatory and career reengineering modules designed and delivered by highly experienced tutors. Modules include Process Biotechnology, Manufacturing and Processing Technology, GMP, Environmental Management and Technology Transfer.

Ideal candidates must be able to demonstrate that they are on the live register for 3 – 6 months. Applicants must possess a minimum qualification at level 6 of a Higher Certificate in Science, Engineering or related discipline.

Applications must be made via www.Bluebrick.ie by July 14th 2011. Applicants should note that attending the programme does not impact on their social welfare payments.

Further details on www.bluebrick.ie

The GlycoBase 3+ Database is intended to give biopharmaceutical manufacturers a timely and powerful tool for confirming the structure of various glycosylated proteins. Armed with more rapid and accurate information about glycosylation during the various stages of the manufacturing process, biopharmaceutical manufacturers can gain a greater degree of control over their manufacturing process in line with regulatory guidelines aimed at guaranteeing safe and efficacious biotherapeutics.

Recent advances in chromatographic approaches are leading to better resolution, sensitivity, and speed during the qualitative and quantitative analysis of protein glycosylation. As a proven approach for analyzing biomolecules and the glycan structures attached to them, UPLC is a potent tool for determining the relative proportions of each glycan structure in a pool.  

The Waters^® UPLC Glycan Analysis Solution features an ACQUITY UPLC^® BEH Glycan Separation Technology column and an ACQUITY UPLC System with fluorescence detection (FLR) to separate the released glycans of biopharmaceuticals as their 2-aminobenzamide (2-AB) derivatives. The UPLC Glycan Separation Solution provides robust, high-resolving, reproducible, and rapid methods that outperform analyses by HPLC.

The combination of NIBRT’s database together with the Waters UPLC Glycan Solution can readily assign potential glycan structures - complex, neutral, high-mannose, and sialylated - to each UPLC peak by matching to a dextran hydrolysate ladder (GU values). Exo-glycosidase array digestion products can also be assigned using the same bioinformatics platform, allowing the monosaccharide sequences and linkages of the oligosaccharides to be confirmed. The technology can be tailor-made to confirm structures present in samples analyzed routinely or to identify unknown or unexpected glycans.

In an application note, Waters describes its methodology for glycan analysis by UPLC in greater detail.

For more information: www.waters.com/glycans 

About Waters Corporation (www.waters.com)

For over 50 years, Waters Corporation (NYSE:WAT) has created business advantages for laboratory-dependent organizations by delivering practical and sustainable innovation to enable significant advancements in such areas as healthcare delivery, environmental management, food safety, and water quality worldwide.

Pioneering a connected portfolio of separations science, laboratory information management, mass spectrometry and thermal analysis, Waters technology breakthroughs and laboratory solutions provide an enduring platform for customer success.

With revenue of $1.64 billion in 2010 and 5,400 employees, Waters is driving scientific discovery and operational excellence for customers worldwide.

About NIBRT (www.nibrt.ie)

NIBRT - National Institute for Bioprocessing Research and Training, Dublin, Ireland is a centre of excellence that supports the biopharma sector by offering research platform solutions for bio-manufacturing and provides tailored accredited industrial training and academic educational programmes to students in purpose-built flexible and modern bioprocessing facilities. For further information please refer to www.nibrt.ie.

#  #  #

Waters, UltraPerformance LC, UPLC, ACQUITY UPLC, and ACQUITY are trademarks of Waters Corporation.

Waters Corporation:

Brian J. Murphy
Waters Corporation                                
Public Relations Manager
+1 508-482-2614
brian_j_murphy@waters.com

NIBRT:
Killian O’Driscoll
Director Projects
Office: +353 1 716 1624
killian.odriscoll@nibrt.ie

Corporate – Academic Partnership to Create World’s First UPLC Glycan Database for More Accurate and Expedient Protein Glycosylation Assessment For Immediate Release

MILFORD, Mass. and Dublin, Ireland – May 6, 2010 – Waters

Corporation (WAT:NYSE) and Ireland’s National Institute for Bioprocessing Research and Training (NIBRT) announced today a collaboration that will create the world’s first database for glycan analysis by UltraPerformance Liquid Chromatography® (UPLC®). Expected to be available in 2011, NIBRT will develop, maintain and license the database while Waters and NIBRT will co-market it worldwide.

Manufacturing biomolecules can be notoriously difficult. Correct glycosylation is essential if a protein is to achieve and maintain its correct structure and therapeutic efficacy. Protein glycosylation is

strongly influenced by many environmental factors during cell culture, such as dissolved oxygen, pH, carbon source, and temperature. Any change in any of these conditions at any point in the process can put product integrity at risk. So consistent glycosylation is a sensitive marker of a well-controlled process.

Given the number of possible glycan structures that can attach to a protein, it can be extremely difficult and time-consuming for life science laboratories to identify and quantify them all.

The new database, to be developed by Professor Pauline Rudd’s group in NIBRT, will be a first-of-its-kind repository of chromatographic retention times for sets of glycan structures associated with a range of biotherapeutics. The aim is to give biopharmaceutical manufacturers a timely and powerful tool for confirming the structure of various glycosylated proteins. Armed with more rapid and accurate information

about glycosylation during the various stages of the manufacturing process, biopharmaceutical manufacturers can potentially gain a greater degree of control over their manufacturing process in line with regulatory guidelines aimed at guaranteeing safe and efficacious

biotherapeutics.

“By combining our know-how in separations and glycan analysis with NIBRT’s expertise in glycobiology we can make fast and accurate glycosylation analysis a reality for the makers of biotherapeutics,” said Dr. Jeff Mazzeo, Director, Biopharmaceutical Business Operations, Waters Division. “Our goal is to simplify and introduce more certainty

into the process of analyzing glycans and making quality

biomolecules.”

“NIBRT’s expertise in glycobiology together with Water’s expertise in separation science will ensure that this collaboration will develop and deliver rapid and robust technologies for the assessment of glycoproteins, while meeting the requirements and guidelines of the regulatory agencies,” said Dr. Maurice Treacy, NIBRT CEO.

Many protein-based biopharmaceuticals are glycosylated proteins. Glycosylation is a form of co-translational and post-translational modification that links glycans to proteins, lipids, and other organic molecules. The glycans directly affect the efficacy and safety of

glycoprotein biopharmaceuticals.

Recent advances in chromatographic approaches are leading to better resolution, sensitivity, and speed for greater reliability during the qualitative and quantitative analysis of protein glycosylation. UPLC is a proven approach for analyzing biomolecules and the glycan structures attached to them and for determining the relative proportions of each glycan structure.

The Waters® UPLC Glycan Analysis Solution features an ACQUITY UPLC® BEH Glycan Separation Technology column and an ACQUITY UPLC System with fluorescence detection (FLR) to separate the released glycans of biopharmaceuticals as their 2-aminobenzamide (2-AB) derivatives. The UPLC Glycan Separation Solution provides robust, high-resolving, reproducible, and rapid methods that outperform

analyses by HPLC.

When available, the combination of NIBRT’s database together with the Waters UPLC Glycan Solution will readily assign glycan structures - complex, neutral, high-mannose, and sialylated - to each UPLC peak for confirming known structures present in a sample or to look at Gu values and identify unknown or unexpected glycans.

In an application note discussing its UPLC Glycan Analysis Solution,Waters describes its methodology for glycan analysis by UPLC in greater detail.

About Waters Corporation (www.waters.com): For over 50 years, Waters Corporation (NYSE:WAT) creates business

advantages for laboratory-dependent organizations by delivering practical and sustainable innovation to enable significant advancements in such areas as healthcare delivery, environmental management, food safety, and water quality worldwide. Pioneering a connected portfolio of separations science, laboratory information management, mass spectrometry and thermal analysis,

Waters technology breakthroughs and laboratory solutions provide an enduring platform for customer success.

With revenue of $1.5 billion in 2009 and 5,200 employees, Waters is driving scientific discovery and operational excellence for customers

worldwide.

About NIBRT (http://www.nibrt.ie): NIBRT - National Institute for Bioprocessing Research and Training,

Dublin, Ireland is a centre of excellence that supports the biopharma sector by offering research platform solutions for bio-manufacturing and provides tailored accredited industrial training and academic educational programmes to students in purpose-built flexible and

modern bioprocessing facilities that will facilitate the expansion of the bio-pharma sector in Ireland. For further information please refer to www.nibrt.ie.

Waters, UltraPerformance LC, UPLC, ACQUITY UPLC, and ACQUITY are trademarks of Waters

Corporation.

Waters Corporation:

Brian J. Murphy

Waters Corporation

Public Relations Manager

508-482-2614

brian_j_murphy@waters.com

NIBRT:

Killian O’Driscoll

Director Projects

Tel: +353 1 716 1624

Mob: +353 87 410 6486

email killian.odriscoll@nibrt.ie

For release May 6th 2010