Safety, Efficacy, Efficiency & Quality: Scaling Your Continuous Processing from Technology to Commercial Manufacturing
Four years in the drug development world isn’t long, and the progress made in continuous processing has been an extraordinary. Thanks to the encouragement of the FDA and maturing technology; both pharma and biotech are starting to adopt continuous manufacturing (CM) in a commercial setting.
Over the last 12 months we have seen major milestones in continuous manufacturing globally – PROSPECT project in the UK, GSK’s announcement of CM facilities in Singapore, Merck has filed an NDA under CM approach, Bill & Melinda Gates Foundation granted $14.3m to Univercells to deploy CM for measles and rubella vaccine continuous manufacturing.
At the 4th Annual CCP Summit we will continue to explore scientific and technology advancements that can help eliminate bottlenecks, and more importantly, will address the quality, upfront investment and business rationale behind the ‘switch’.
Returning to Boston for the 4th time on Jan 28 – 30, 2020 – Get involved now!
This is the one and only CCP meeting bringing together small molecules and biologics experts under one roof for knowledge and experience exchange!
Highlights of the 2020 Summit:
- FDA reveals their Advanced Manufacturing for Complex Biologics Products program to clarify your myths and help you gain early access to engage with the right teams at the agency
- ICH Q13 steering committee members present their latest progresses in draft guidance, and how will this impact your continuous manufacturing in a global framework
- Merck shares their implementation of continuous manufacturing for OSD drug products – and how they built the business case early enough to promote timely entry into development cycle
- Amgen discusses their virtual plant development, moving towards a truly end-to-end continuous manufacturing process by an integrated systems-based modelling, improving their process robustness and control strategy to drive product quality
- Codiak Biosciences, Bristol-Myers Squibb and ImmunoGen showcase their latest technical continuous bioprocessing updates – from upstream to downstream – how CM can provide a more flexible and efficient biomanufacturing
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