Visualisation of sodium chloride freeze-drying and reaching critical temperature using the Lyostat 5
The Lyophilisation Centre at NIBRT
The Lyophilisation Centre of NIBRT is a leading centre of innovation in training and research in the lyophilisation of biologics. The Centre provides access to cutting edge training and research and is equipped with state-of-the-art lyophilization technology.
Background
In 2018, approximately 34% of commercialised biologics formulation products were lyophilised. This number is likely to increase in the coming years with newer biologic modalities such as antibody-drug conjugates which require stabilisation through freeze-drying.
Furthermore, lyophilisation is an important preservation method employed for safe distribution and storage of vaccines, which are often heat sensitive as liquid formulations, requiring complex cold-chain storage and transport. With the impact of the Covid-19 pandemic and the advent of newer biologics modalities, unit operations which facilitate safer and more efficient transport, storage and distribution have never been more relevant.
The Lyophilisation Centre at NIBRT supports the rapidly growing global demand for lyophilization expertise by providing world class training, research expertise and infrastructure.
Equipment
Lyostat 5 - Freeze-drying Microscope
The Lyostat 5 from Biopharma Group is a freeze-drying microscope system which allows visualisation of formulation samples during lyophilisation. This allows for visual determination of critical formulation temperatures (See here). NIBRT use this instrument in training to facilitate understanding of critical process parameters in Lyophilisation and illustrate the criticality of formulation design and knowledge for successful lyophilisation cycle development.
Lyobeta Mini
The Lyobeta Mini from Telstar is a 2-shelf bench-scale version of the Lyobeta 3PS. While the Lyobeta Mini at NIBRT does not have some of the features mentioned for the Lyobeta 3PS (e.g. pneumatic stoppering) it can still replicate many the same process cycle parameters used at industrial scale and is configured with an external condenser. Furthermore, the unit is run with Lyosuitelab 3.0 software, allowing easy transfer of operational knowledge, training and processes between both Lyobeta units.
Lyobeta 3PS
The Lyobeta 3PS from Telstar is a 3-shelf pilot-scale lyophiliser with an external condenser and the ability to replicate many of the processes cycle parameters used at industrial scale. It also can perform controlled nucleation (LYONUC), pneumatic stoppering, shelf and product temperature monitoring as well as precise chamber pressure monitoring using a combination of Pirani and Capacitance probes. In addition, NIBRT also have a sample thief available for mid-cycle extraction of vial samples, useful for product and process development. The Lyosuitelab 3.0 software provides an easy interface for unit control, cycle design, data recording and interpretation.
Training
November 5th 2021– Expert and Vendor Speaker Event
In collaboration with LyoHub and the Ireland Lyophilisation Community of Practice – NIBRT will bring global expert speakers and leading vendors in lyophilisation together to discuss current challenges and future trends in lyophilisation of biologics.
This will be a unique opportunity for anyone in the Lyophilisation space discuss and troubleshoot the issues they face and to learn about exciting new technologies and solutions which may address their business needs.
Speakers include:
- Alina Alexeenko is a professor of aeronautics and astronautics and professor of chemical engineering at Purdue University.
- Dr. Duncan of Lighthouse who is responsible for developing applications for process monitoring and finished product inspection.
