BioPharm International - September 2019

BioPharm - Regulatory Sourcebook

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Jeff Hou, Ph.D. Manager, Cell Culture Development Pharma Services Princeton, NJ PROCESS & PURPOSE HOW A SMALL STARTUP WAS ABLE TO SCALE UP, WITHOUT LOSING THEIR PRECIOUS MATERIAL. MADE WITH Jeff faced a dilemma: how to complete a large biomanufacturing scale up with the very small amount of material his client gave him. And the stakes were high. His client had spent a lot of time and money developing this potentially revolutionary Alzheimer's treatment. Any wasted material would put the execution of the clinical trial at risk, and possibly risk the future of the entire program. Jeff knew the process needed to be perfect. So, his team worked tirelessly to fi nd ways to improve the cell culture performance. They examined key process parameters and even completed additional work in the process development laboratory to ensure success. The result was a fl awless scale up and, most importantly, a potential breakthrough drug was able to get into the clinic. Learn more at www.patheon.com and at Thermo Fisher Scientifi c's Booth #643. © 2019 Thermo Fisher Scientifi c Inc. All rights reserved. API BIOLOGICS EARLY & LATE PHASE DEVELOPMENT CLINICAL TRIAL SOLUTIONS LOGISTICS SERVICES COMMERCIAL MANUFACTURING

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