Reference Standards for Potency Assays – Considerations for the Preparation and Storage of In-House Standards
Volume 1, Issue 5: As potency of a biopharmaceutical product is determined by bioassay relative to a reference standard (RS),…
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Category: BEBPA Publications
Before the Beginning Comes the Question: A Journey Through the Statistical Fundamentals of Comparability
Volume 1, Issue 4: Complex biopharmaceutical processes often require changes to satisfy production scaling, cost optimization, product safety and efficacy,…
Mini History of the Potency Bioassay and its Regulatory Drivers
Volume 1, Issue 3: The concept of potency assays came into being specifically for biopharmaceutical products. Originally, these products were…
Synopsis: BEBPA’s 2023 Host Cell Protein Conference in Review
Volume 1, Issue 2: Dr. Denise Krawitz provided an excellent wrap up on the last day of BEBPA’s 11th Annual…
Technical and Regulatory Considerations for Cell and Gene Therapy Raw Materials
Volume 1, Issue 1: Quality attributes of cell and gene therapy (CGT) products, also referred to as advanced therapy medicinal…
