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Minimize Risks in Late-Stage Projects Through Quality Partner Selection
BPI Contributor
June 12, 2024
30 Min View
Date: Jun 12, 2024
Duration: 30 Min
Sponsored by Avid Bioservices
This webcast features: Pramthesh Patel, Vice President, Process Development, Avid Bioservices.
The development and delivery of pharmaceutical drugs require a complex process involving stringent clinical assessments and CMC packaging considerations. CDMOs play a crucial role in manufacturing drugs and meeting CMC requirements and timelines.
However, recent changes in the CDMO landscape and geopolitical uncertainties have raised concerns about their ability to meet these obligations.
This case study highlights Avid Bioservices' ability to address challenges for clients with late-stage projects at other CDMOs. Issues with timeline adherence and CGMP compliance led clients to seek alternative solutions. Avid facilitated a seamless tech transfer, integrated the projects into their facilities, and executed a process performance qualification (PPQ) campaign without major setbacks, achieving an on-time product launch.
Key Takeaways:
Effective tech transfer strategies are essential.
Client/CDMO collaboration is vital.
Reliable operational performance is crucial in drug development and manufacturing.
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Through a combination of sessions led by experts from the likes of GSK and Pall Biotech, as well as group discussions with your peers, you will learn how to bring a biopharmaceutical drug to market. Each day will be chaired by a different member of the BioProcess International Academy faculty and there will also be time for networking and Q&As with the experts.
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