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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 1, 2018
Impurity Testing of Biologic Drug Products
Experts share insights on the various methods used for purity and impurity analysis of therapeutic...
January 18, 2018
What’s in Your SOP?
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp...
November 16, 2017
Evaluating Surface Cleanliness Using a Risk-Based Approach
Regulated companies that use automated cleaning applications have always struggled with correlating...
September 21, 2017
Bioburden Control in the Biopharmaceutical Industry
The biopharmaceutical industry has witnessed tremendous breakthroughs during the past few years. However, this advancement...
September 21, 2017
Impact of Media Components on CQAs of Monoclonal Antibodies
Recombinant protein products have made a revolutionary impact on human healthcare by enabling mass...
September 7, 2017
The Role of Quality Standards for Biomanufacturing Raw Materials
Successful pharmaceutical manufacturing strategies depend on raw materials that are of good quality.
September 6, 2017
Column Selection Guide for ÄKTA Systems
Use this guide to facilitate your selection of prepacked chromatography columns. The guide includes...
August 11, 2017
Process Chromatography: Continuous Optimization
Cell-culture and fermentation are high-yielding processes that effectively produce...