Biomanufacturing figures gather to advance the disposables industry
Last week, key figures in the biopharma manufacturing industry came together to shape the future of the industry, exchange best practice tips and spot the new opportunities on the horizon for the market.
Chaired by Tony Hitchcock -Technical Director of Cobra Biologics- the first day of the conference opened by looking at standards and guidance in the single use systems industry. Debate was had on the lack of global clarity on the definition of the term standard in the single use systems industry. Conversations circled around the difference between the meaning of Standard - enforceable by law- to the meaning of standard, to avoid causing industry confusion.
Michael Eakins, Vice Chair, USP Packaging and distribution expert committee provided the current compendial perspectives on plastic components and systems used in the manufacturing of a drug product.
The session looked at process related impurities – process equipment related leachables which could adversely affect the quality of the end product. Of course there is a need to assess plastic manufacturing components but should all components or systems require evaluation to the same degree? It was deemed that risk assessment approaches (for example risk matrixes) and deductive reasoning should be deployed rather than tick box mentalities.
Bill Whitford, Strategic Solutions Leader of GE Healthcare raised the sustainability discussion, noting that sustainability has become one of the six major trends in pharma. This trend is very ambitious in an industry that is becoming ever more complex, with increasing competition to have higher productivity levels, higher plant utilisation and expanding manufacturing standards. Looking ahead, global trends are set to drive for more sustainable pharma manufacturing and production through public pressure, prominence and even regulatory control. This is seen already with the recent acknowledgement of the 12 greenest companies in biopharma.
A life cycle assessment was presented in this session - a rigorous assessment to identify, catalogue and organise individual parameters to reach a representative examination of the actual environmental impact from a product’s live cycle. This can be used within biomanufacturing to identify what levels of environmental stress occur from which processes so priorities can be made when making processes greener.
Aidan Sexton, Senior Process Validation Engineer Janssen Biologics tackled the ever hot topic of leachables, proposing a phased approach to risk assessments as per the drug discovery route. E&Ls can impact drug quality but also performance. In his session entitled: BPOG’s Best Practices Guideline for Mitigating Risk from Leachables in Polymeric Single-Use Components Used in Biomanufacturing, he evaluated five key areas for risk scoring leachables:
1. Distance along the production stream: Early stages upstream will have lower risk and this will increase all the way up to filling and formulation stages.
2. Temp of exposure: The higher the temperature the more likely leaching will occur, lower temperatures are likely to have lower or more negligible levels.
3. Exposure duration
4. Process fluid interaction material compatibility
5. Dilution rate – Exposure surface area to process liquid volume.
Pre-treatment steps such as autoclaving and gamma radiated parts have unique leaching propensities and so require dedicated assessing.
The quality of the industry’s single use mechanical connections appeared on the radar of some with complaints regarding current definitions, testing requirements to minimise failures and transparency measures such as inspections to assist end users when purchasing.
Day two looked at innovative technologies in the industry, process and bioreactor development optimisation with computational fluid dynamics as well as various single use system case studies from biopharma firms.
Companies present included the likes of GSK Biological, Watson Marlow, Allergan, Oxford Biomedica and Fujifilm Diosynth Biotechnologies.
Footage of the event is to follow shortly.
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