Madhav Kamat, PhD, RPh, is a senior principal scientist at Biopharmaceutics R&D, Drug Product Processing and Packaging Technologies, Bristol-Myers Squibb Company, One Squibb Drive, New Brunswick, NJ 08993.
Evaluating Functional Equivalency as a Lyophilization Cycle Transfer Tool
The authors describe a comprehensive methodology for establishing functional equivalence among various lyophilizers.