Controlled Nucleation during Lyophilization to Improve Cake Appearance & Protein Stability



July 12, 2016

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  • To view the full webinar, please visit: Controlled nucleation has received considerable attention because it allows better process control during freezing and a faster sublimation process due to the lower cake resistance formed at a higher nucleation temperature. The controlled nucleation process will be discussed, and the latest data in both vial and dual chamber syringe will be presented. Our case studies examined the performance of controlled nucleation using several different proteins, and the quality attributes from both high and low concentration products were compared side-by-side to those from the cycles without controlled nucleation. Improved product quality attributes including cake appearance, reconstitution time and stability will be presented.


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