Potency Method Commutability Study Leads To Late-Stage Bioassay Strategy Change: A Case of Unexpectedly High Sensitivity to Oxidation

Volume 2, Issue 6: Bioassay Development employs a phase-appropriate strategy to fulfil clinical and commercial regulatory requirements. This approach involves customizing the design and validation of assays according to the current stage of clinical development, adjusting the complexity and validation level to match the clinical trial phase. In the case of our drug modality, a fully reflective mode of action non-cell-based assay could in principle be submitted as late as the BLA stage, as the drug is intended to bind a soluble ligand, thus inhibiting the ligand-receptor interaction

Reference Standards for Biosimilars

Volume 2, Issue 5: The importance of suitable reference materials for potency assays and other relative format assays in protein therapeutics cannot be overstated. Since potency is quantified through comparison to a Reference Standard, the accuracy of potency and system suitability parameters depends entirely on the quality of the Reference Standard.

Robust Regression: An effective Tool for detecting Outliers in Dose-Response Curves​

Volume 2, Issue 4: Outliers are abnormal values in a data set and are described as “inconsistent with the known or assumed data distribution” [1]. In potency testing, outliers can occur either in the assay data set or as an extreme relative potency (RP) result in the reportable value. This article focuses on abnormal values in bioassay data sets following a non-linear regression.

Tech Briefing: Bioassays For New Product Modalities

As a staring place, this is not a bad effort at defining new modalities. The widely varying product types highlights the scope of the problem about how to assure product potency during clinical trials and later during the commercial phase. A look at the two most common of the new modalities; gene therapy (GT) and cell therapy (CT) gives one an idea of the wide varying issues. A gene therapy product with a single expressed protein might have a single mechanism of action (MoA). 

Reference Material Day 1 Panel Discussion

A transcript of the Day 1 “Question and Answer Session” from the BEBPA Virtual conference focused on Reference Material for late-stage clinical and commercial pharmaceutical material is now available. The conference was held on February 25 to 26, 2025 (View conference brochure here).  The conference was well attended by many small and large biopharmaceutical companies, all trying to find the best path to developing and maintaining an in-house reference program. To get the best practices and ideas of future approaches we reached out to regulators, individuals working at standard organizations, statisticians, managers from industry running reference programs supporting global commercial products and consultants who have been involved in solving existing problems in the reference world.

David Lansky 2025 USB Slides

BEBPA Blog David Lansky 2025 USB Slides View PDF Slides

2025 USB Conference Survey Results (PDF)

BEBPA Blog 2025 USB Conference Survey Results (PDF) View PDF Survey

2025 RFM Conference Survey Results (PDF)

BEBPA Blog 2025 RFM Conference Survey Results (PDF) View PDF Survey

An Interview with BEBPA’s President: Laureen Little, Ph.D.

BEBPA had a chance to sit down with Laureen Little, the President of BEBPA and producer for the upcoming US Bioassay Conference happening March 24-26, 2025 in Tucson, AZ. We asked her about what she sees is happening in the potency field.

Unveiling Host Cell Protein (HCP) Coverage in Three-Dimensions (3D): Why It Matters and How to Achieve It

Host cell proteins (HCPs) are impurities derived from the host organism used in the production of genetically engineered biopharmaceuticals. Their removal is crucial for the safety and efficacy of the final product, as they can provoke unwanted immune responses and/or have undesired biological/enzymatic activities[1-4]. The sandwich enzyme-linked immunosorbent assay (ELISA) remains the most widely used method for HCP quantification throughout biopharmaceuticals product development lifecycle due to its high sensitivity, throughput, and selectivity in complex sample matrices.