Applied Water & Steam for Engineering
This course adopts a hands-on approach to the management, maintenance and operation of water and steam systems.
Read more »Biocontamination Control
This module will introduce current standards for cleanrooms, sterile manufacturing and aseptic processing. Examples of contamination control issues will be provided in a workshop environment. Hands on laboratory exercises will be combined with interactive plant exercises The course will be run in a state of the art bioprocessing facility at NIBRT, which contains both disposable and stainless steel industrial type plant.
Read more »Biopharmaceutical Industry Regulation and Management
This course will provide a high level overview of the regulatory environment and the roles and responsibilities in which biopharmaceutical engineering professionals must operate. The focus will be on the current good manufacturing practices (cGMP) associated with the manufacture of biological medicinal products for human use. The course will take both a current and prospective look at the ever evolving regulatory requirements, applying the principles of quality by design and continuous improvements during pharmaceutical development, facilitated using a range of risk management tools. Process validation considerations for biopharmaceutical manufacturing will also be addressed, in terms of the process and quality attributes considered to be critical. It will also look at the cGMP expectations throughout the lifecycle of a product including process scale-up and post approval changes (SUPAC) managed through self inspection programs and audits.
Read more »Clean in Place System
Theory of CIP generation and distribution. Practical hands-on servicing of CIP generation and distribution systems.
Read more »Cleanroom Operations
This course provides practical and theory instruction in best practice for clean room operations in a biopharmaceutical environment
Read more »Column Packing
This 2-day course aims to provide an introduction to column packing techniques used typical biopharmaceutical production process. Trainees will receive extensive hands on experience of column packing including flow-packing and pack-in-place methodologies. Training will be provided in an industrial bioprocessing type environment with the latest equipment.
Read more »Downstream Processing: Principles in Practice
This 3-day course examines the downstream processing aspects of a typical biopharmaceutical production process used in the production of recombinant protein for human therapeutic use. This will include both hands-on practical and lecture components. Trainees will receive extensive hands on experience of downstream processing operations including chromatography, column packing, ultrafiltration/diafiltration and filter integrity testing. Training will be provided in an industrial bioprocessing type environment with the latest equipment.
Read more »Energy Management in an Industrial Plant
A comprehensive introduction to the theory and techniques of Energy Management with particular application to an industrial plant.
Read more »Facility Design and Operation
This course will provide an overview of the technical and managerial challenges associated with the design and construction of a biopharmaceutical manufacturing facility. It will address all the major elements of these projects from site master planning through conceptual and detailed design and onto commissioning and qualification. It will also cover such associated project aspects as overall planning, budgeting and the organisational systems and structures required to successfully execute such major investments. An overview of how biopharmaceutical manufacturing facilities operate will also be provided i.e. the design of the facility from the material and personnel flows through to the process controls and automation
Read more »Fill Finish and Aseptic Processing
This is a comprehensive, practical and hands on course based on current aseptic techniques related to working in a clean room and isolator environment. The course includes microbiological monitoring, sampling, testing, validation, identification methods and techniques. The course will be held in the NIBRT facility which comprises a quasi class C compounding area and a class B production area (containing a class A vial filling line, LAF cabinets and an isolator).
Read more »Filter Integrity Testing
This 1-day course examines the current filter integrity testing techniques used in a typical biopharmaceutical production process. Trainees will receive extensive hands on experience in filter integrity testing methods including bubble point, diffusion and water intrusion testing. Training will be provided in an industrial bioprocessing type environment with the latest equipment.
Read more »Freeze Drying: Product and Process
This in-depth 2-day course will provide up to date information on the key aspects and practical application of Freeze Drying. The course takes a detailed look at formulation, cycle development, techniques of analysis and design for successful freeze drying. An entire session is dedicated to the freeze drying of proteins and special attention is given to unique set of obstacles presented when freeze drying proteins.
Read more »Fundamentals of Bioprocess Engineering
This module will provide an introduction to the fundamentals of biochemical and bioprocess engineering. Both upstream and downstream operations and equipment will be covered in detail.
Read more »Glycan Analysis 1: UPLC
This course will provide lectures and hands-on practical sessions on the subject of glycobiology and glycoanalytics, allowing students to gain a broad overview of the concepts, strategies and research techniques that are used in analytical glycobiology.
Read more »Glycan Analysis 2: UPLC/MS
This course will follow on from the Glycan Analysis 1 course and will provide more advanced lectures and hands-on practical sessions on glycan analysis by UPLC-MS. The course will also comprise interpretation of UPLC-MS glycan data and bioinformatics tools for glycan MS data such as GlycoBase 3.0+, GlycoworkBench and UniCarb DB.
Read more »Harvest and Centrifugation
This 2-day course aims to provide hands on experience of the harvesting of mammalian cells using centrifugation and microfiltration plant in a quasi GMP operating environment. Waste cells will be neutralised. Permeate will be processed to remove cell fractions using clarification skids before transfer prior to final processing downstream.
Read more »Introduction to Biopharmaceutical Operations
The aim of this course is to introduce the biopharmaceutical industry and its associated processing principles and techniques. The course will expand the students’ knowledge and understanding of bioprocessing in the industry, and will improve the students’ analytical abilities and problem solving methodologies in this area.
Read more »Introduction to Chromatography
This 2-day course aims to provide a high level introduction to chromatographic techniques used in a typical biopharmaceutical production process. Trainees will receive extensive hands on experience including column packing and chromatographic processes (column equilibration, sample loading, elution, cleaning and storage). Training will be provided in an industrial bioprocessing type environment with the latest equipment.
Read more »Introduction to Cleanroom Microbiology
All personnel working in a cleanroom environment should have a thorough understanding of the microbiology of their area, the importance of cleanroom classifications, environmental monitoring and associated controls, procedures and regulations.
Read more »Introduction to Disposable Technology
Disposable technology is finding widespread use in the biopharma industry in the areas of upstream, downstream and fill finish. This 2-day course will look at the advantages and disadvantages of disposable technology and it’s impact on the biopharma manufacturing industry. Trainees will be able to get hands on experience of a wide range of equipment actually used in industry.
Read more »Introduction to Recombinant DNA Technology
This course will provide the student with the basic background knowledge of genetics and molecular biology which underpin the newer disciplines of bioinformatics & genomics (with particular emphasis on the human species). It will also introduce the student to the philosophy underlying genome projects in general together with a review of the history, organisation, achievements and current goals of the Human genome project in particular. It also highlights some of the ethical and social issues which arise from genetic studies.
Read more »Introduction to Tangential Flow Filtration (TFF)
This 1-day course aims to provide a high level introduction to tangential flow filtration (TFF) used in a typical biopharmaceutical production process. Trainees will receive extensive hands on experience of TFF operations including ultrafiltration (UF) and diafiltration (DF). Optimum operating conditions will be determined at lab and pilot scale. Training will be provided in an industrial bioprocessing type environment with the latest equipment.
Read more »Legislation/Regulatory Affairs for Biopharmaceutical Products
This course aims to provide students with a detailed knowledge and understanding of biopharmaceutical legislation in EU and US. It explains the legislation applicable and guidelines available to biopharmaceutical manufacturers.
Read more »Mammalian Cell Culture Scale Up & Inoculum
This 2-day course gives a detailed introduction to the initial cell culture processing aspects of a typical biopharmaceutical production process used in the development of recombinant protein for human therapeutic use. This will include both hands-on practical and theory components. This course deals with the initial launch of the production process starting with the recovery of cells from the cell bank and scale up. Trainees will use aseptic technique to thaw and culture cells and analyse growth in shake flasks. The course will then progress with an overview of the scale up process from shake flask to small scale bioreactors (7L glass bioreactor and 5L disposable bioreactor). Trainees will then build on the knowledge and experience gained during the course theory and practical sessions and start a production batch by inoculating the 30L stainless steel bioreactor.
Read more »Mammalian Cell Culture Scale Up Processes
This 1-day course gives a detailed introduction to the initial cell culture processing aspects of a typical biopharmaceutical production process used in the development of recombinant protein for human therapeutic use. This will include both hands-on practical and theory components. This course deals with the initial launch of the production process starting with the recovery of cells from the cell bank and scale up. Trainees will use aseptic technique to culture cells and analyse growth. Trainees will be introduced to small scale cell culture procedures using 5L disposable bioreactors and 7L glass bioreactors.
Read more »Pharmaceutical Water & Steam Systems
Pharmaceutical water and steam systems – Purified Water, Ultra-Purified Water, Water for Injections (WFI) and Clean Steam.
Read more »Principles of Biopharmaceutical Engineering
The aim of this course is to introduce the student to the biopharmaceutical industry and its associated processing principles and techniques. The course will expand the students’ knowledge and understanding of bioprocessing in the pharmaceutical industry as a whole and will improve the student’s analytical abilities and problem solving skills in this area.
Read more »Principles of Cell Biology
This course will provide the trainee with a fundamental understanding of cell biology, particularly applied to biopharmaceutical processing. The course aims to extend the trainees understanding of structure, function and growth of cells in a practical, industrial type environment. The use of the inoculum laboratory in scaling up the cell line to establish cultures for production will be demonstrated.
Read more »Process Measurement, Control & Digital Communications
This course, developed in association with Endress+Hauser and Rockwell Automation, offers a well balanced learning experience between theory and practical. Based on Bio and Pharma production and cleaning processes, this training provides a unique opportunity to understand all process measurements and controls systems.
Read more »Protein Characterisation Techniques 1: Introduction
This practical course provides students with specialised knowledge in the theory, practice and interpretation of basic protein analysis techniques, as well as practical experience with the instrumentation that is routinely used.
Read more »Protein Characterisation Techniques 2: Intermediate
This course provides practical and theory sessions on intermediate protein characterisation techniques and gives hands-on experience on the instrumentation that is routinely used.
Read more »Purified Water System
Theory of water pre-treatment and purification. Practical hands-on servicing of plant type water purification equipment.
Read more »Risk Assessment and Management Principles
Risk management is a practice with processes, methods, and tools for managing risks in a project. It provides a disciplined environment for proactive decision making to continuously assess what could go wrong within an organization and with its products. This course provides a good understanding of the principles and applications of risk management in a biopharmaceutical environment.
Read more »Sterilisation In Practice
This 2-day course aims to provide hands on experience of the sterilisation of a modern industrial computer controlled bioreactor, complete with all instrumentation. Computer simulations will be provided to fast track theory and progress on line before hands on practice on plant.
Read more »Upstream and Downstream Processing: Principles in Practice
This 4-day course examines both upstream and downstream processing aspects of a typical biopharmaceutical production process used in the production of recombinant protein for human therapeutic use. This will include both hands-on practical and lecture components. This course involves an introduction to the upstream process beginning with mammalian cell culture scale up. Trainees will use aseptic technique to culture cells and analyse growth. Trainees will then build on this knowledge with hands on practical experience in the NIBRT upstream bioprocessing suite by preparing stainless steel bioreactors for cultivation with steam in place (SIP) procedures and cultivation operation of the bioreactor. Trainees will receive extensive hands on experience of downstream processing operations including chromatography, column packing and ultrafiltration/diafiltration. Training will be provided in an industrial bioprocessing type environment with the latest equipment.
Read more »Upstream Processing: Principles and Processes
This 3-day course gives a detailed introduction to the upstream operations in a biopharmaceutical production process used in the development of recombinant protein for human therapeutic use. This will include both hands-on practical and theory components. During this course trainees will be introduced to cell culture technique using small scale shake flasks. Trainees will then gain hands on practical experience on 150L stainless steel bioreactors using detailed experimental procedures and SOPs to prepare and run a steam in place sterilisation on the 150L bioreactor. Trainees will then build on the knowledge and experience gained during the course theory and practical sessions and start a production batch on the 30L stainless steel bioreactor.
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