Applying Quality by Design to Lyophilization

作者:Sutton Stephanie; Gieseler Henning; Mayeresse Yves; Nail Steven; Page Trevor; Pikal Michael J; Steiner Manfred
来源:Biopharm International, 2012, 25(5): 22-+.

摘要

Lyophilization is often necessary for pharmaceutical products to improve stability or shelf-life. However, the process can present difficulties, particularly when scaling up from the laboratory to commercial production. We bring experts together to discuss best practices for developing a lyophilization process, including quality by design and design space.

  • 出版日期2012-5