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February 26, 2015
Quality by Design and Extractable and Leachable Testing
Biopharmaceutical packaging performs several vital functions in assuring the drug product safety.
January 29, 2015
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
This article discusses efforts to limit polymer degradation without significantly impeding cell growth.
October 29, 2014
Continued Process Verification for Biopharma Manufacturing
Continued process verification (CPV) is the activity that provides ongoing verification of the...
October 29, 2014
Application of Quality by Design to Viral Safety
The biotech industry has begun to implement a quality-by-design (QbD) approach to ensure the...
October 1, 2014
Challenges and Trends in Biopharma Facility Design
Experts discuss the future of modular manufacturing and the challenges that biopharma manufacturers...
September 1, 2014
Challenges of Protein Aggregation During Purification
Removal of protein aggregates from biologic APIs is crucial due to their potential to increase...
December 29, 2013
Quality by design for biotechnology products—part 1
Quality by Design (QbD) is a concept applied to the design and development...