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February 14, 2019
Supply Chain Challenges for Single-Use Systems
The implementation of single-use systems (SUS) for biopharmaceutical manufacturing as an alternative...
December 20, 2018
Achieving Process Balance with Perfusion Bioreactors
Perfusion cell-culture processes have been used for more than two decades for the production of...
September 27, 2018
Ensuring Viral Safety of Viral Vaccines and Vectors
Vaccines, including viral vaccines, are a crucial invention in human history and continue to...
June 7, 2018
Putting Viral Clearance Capabilities to the Test
Drug products based on live cells have an inherent risk for viral contamination that could…
April 12, 2018
Understanding Validation and Technical Transfer, Part I
Many new biological entities use unique processing flows and steps that can require non-traditional...
March 13, 2018
Applying GMPs in Stages of Development
Regardless of the phase of development and the level of GMPs being applied, there should…
March 1, 2018
Efficient Cleaning-In-Place Methods for Protein-Based Antibody Affinity Chromatography Resins
This whitepaper discusses cleaning of affinity resins for purifying monoclonal antibodies and Fab fragments…
February 15, 2018
Preclinical Evaluation of Product Related Impurities and Variants
The approaches for sample preparation of preclinical evaluation of safety and efficacy are...
January 18, 2018
What’s in Your SOP?
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp...