A recent trend in drug development by established biotech companies has been the acquisition (in-licensing) of promising drug candidates. An established biotech company plays the role of providing the resources and expertise needed to bring this drug quickly to patients. But, based on the development experiences of the innovator company, process development of in-licensed drugs can be challenging.<br/><br/>This presentation will discuss the challenges and learnings from the rapid process optimization of an acquired early stage candidate to ensure Clinical trial material would meet Pfizer’s high quality standards. Increased complexity arose due to the stage of development when the molecule was acquired and the candidate design where platform techniques were not applicable.<br/><br/>Development was enabled by Pfizer’s high throughput screening lab to characterize the existing process as well as test alternative chromatography resins using batch binding and RoboColumns. Improvements were verified against the current process during lab and pilot scale confirmation runs. Optimization of this 4-column process was performed in 4 weeks and process changes were implemented immediately during the ongoing GMP manufacturing campaign.

Rapid downstream process development of an in-licensed non-platform protein

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.