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.

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 similarly vital importance. Biologic drugs are highly complex and impurities can arise during production, purification, and storage. Unlike small-molecule drugs, biologics are susceptible to a wide range of contaminants—including host cell proteins, endotoxins, and other bioactive substances that can affect their safety, efficacy, and stability. Detecting these impurities requires robust analytical tools, and bioassays can play a central role in the quality control of these products.

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 and data scientists, anybody with a little bit of time on their hand can train themselves into becoming a “prompt engineer” and call themselves an expert within weeks (hours?) of their learning journey. This short article aims to raise awareness about how impactful AI can be for the pharmaceutical industry and especially for assay scientists.

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 suitable for its intended purpose. Indeed validation, has a long history within the pharmaceutical industry. Approximately twenty years ago (1994 and 1996), the International Council for Harmonisation (ICH) first published two guidelines for the Validation of Analytical Methods in two documents ICH Q2A and ICH Q2B. The first document was a list of definitions and terminology, the second was a how-to guideline.

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 and revised by the Statistics Expert Committee.

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. Any residual HCPs can pose diverse risks to quality, safety, and developability of a drug. There is manufacturing and clinical history indicating certain classes of HCPs which have been problematic, e.g. HCPs which,

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, MD, Dr. Denise Krawitz gave her final summary of conference highlights. We thought it would be fun and informative for those of you who could not join us to hear a synopsis of the 3-day conference from her perspective. Below you will find excerpts from her summary:

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, and validated methods adhering to ICH principles with robust statistical process control (SPC) may raise questions about the continued necessity of dedicated ACs in some cases. This might lead to considering AC samples fulfilling a similar role to QC samples within validated, controlled methods under GMP regulations.