BEBPA Blog
Category: Industry Voices
Beyond Potency: Leveraging Bioassays for Contaminant Testing
Volume 2, Issue 3: Bioassays are used extensively for potency determination of biologic therapeutics. However, ensuring the purity and safety of biologic drugs is of
AI in Bioassay: The Good, The Bad, The Ugly.
Volume 2, Issue 2: For decades, the study and development of AI was reserved to high level academics. Today, much to the amusement of statisticians
Characterization of Precision and Accuracy and Total Analytical Error for Bioassays
Volume 2, Issue 1: We tend to think analytical validation is a fairly straight forward, almost box checking activity if a method is well-developed and
The Role of USP Chapters in Bioassay Development and Validation
Volume 1, Issue 10: Design, development and validation of bioassays has been part of the USP/NF for nearly 50 years. The chapters are regularly reviewed
Critical HCPs: What to do with them?
Volume 1, Issue 9: Host cell proteins (HCPs) are a complex blend of various proteins that need to be depleted during the production of biotherapeutics.
Host Cell Proteins Remain a Hotly Debated and Emerging Topic
Volume 1, Issue 8: At the finish of the recent 12th annual Host Cell Protein Conference (May 14-16, 2024) sponsored by BEBPA in College Park,
Value-Driven Use of Assay Control Samples in the Relative Format Biological Assays
Volume 1, Issue 7: The selection and implementation of Assay Control (AC) samples in bioassays require practical, risk-based considerations throughout the method lifecycle. Well-established, controlled,
Outliers in Dose-Response Curves: What are they, and what can we do about it?
Volume 1, Issue 6: Potency assays are designed to gauge the biological activity or binding affinity of a test sample in relation to a reference
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), the development and establishment of
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, and the constantly evolving regulatory
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 complex and ill-defined mixtures, produced
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 HCP Conference held in May
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 products (ATMPs) in the EU,