Q&A: APC Experts Define Process Portability [VIDEOS]
Process portability is a concept pioneered by APC which encompasses the capability to seamlessly transfer robust manufacturing processes across different facilities or locations without compromising product quality or efficiency.
Given the surge in CDMO acquisitions and geopolitical uncertainties, pharmaceutical companies need to future-proof their manufacturing operations against potential disruptions. A strong, robust process founded in strong science considers the entire CMC life-cycle and can be manufactured anywhere business requires.
Those tasked with developing a process need to focus less on ‘filling their reactors’ and more on getting a deep understanding at a kinetic and thermodynamic level of the factors underpinning each unit operation of a given process - a science-first approach to development, not a process dictated by capacity at the CDMO’s site.
Below 4 CMC experts outline key aspects of process portability and why it’s critical in today’s CDMO landscape:
Q: What is the concept of ‘Process Portability’?
Q: Why De-couple Process Development
from Manufacturing?
Q: What should pharma companies consider
when re-thinking relationships with CDMO’s?
Q: How does Process Portability
Future-Proof Medicines?
Learn more about Process Portability
Learn more about CMC: Chemistry Manufacturing & Controls – But who's really in control?
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