Tech Briefing: Regulatory Guidances for Potency Assays

The potency bioassay is a keystone assay supporting the regulatory quality assurance strategy for verifying that products released for commercial use have similar biological activity to those used in clinical trials to demonstrate efficacy. We routinely gather at the annual BEBPA European Bioassay Conference to discuss the best scientific practices for developing potency assays.

Tech Briefing: How Good is Good Enough?

How good is good enough? As scientists we are trained to make our assays not just good but the best. However, sometimes taking that last step, going from good to best is a nearly impossible feat and requires more resources than it took to develop the assay in the first place. That brings us back to how good is good enough? (Hint, the answer is NOT: “good enough to pass regulatory scrutiny”). A typical answer, most of us can chant the phrase is that it must be “suitable for use”.

2024 Reference Material Conference Survey Results (PDF)

BEBPA Blog 2024 Reference Material Conference Survey Results (PDF) View PDF Survey

Tech Briefing: The Importance Of Being Potent (with apologies to Oscar Wilde)

The need for potency assays for biopharmaceutical therapeutics has been recognized for some time. The regulatory agencies from all ICH-abiding countries require one or more potency assays as part of the release suite of assays associated with DS and DP. Entire programs have been put on clinical hold for lack of a well-reasoned and supported potency assay.

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.

2024 HCP Conference Survey Results (PDF)

BEBPA Blog 2024 HCP Conference Survey Results (PDF) View PDF Survey

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 preparation (USP 1032; Vølund, 1978). For instance, in the production of a biotherapeutic or vaccine, the potency of material from a new batch can be calibrated in comparison to that of a reference batch material. The concept of relative potency (RP) is derived from the concentration-response functions of the two products. When the test product behaves as a dilution or concentration of the reference product, the two products exhibit a consistent RP. Graphically, concentration-response curves reflecting constant RP differ only through a shift along the log-concentration axis. It is crucial to note that calibration based on a consistent RP value can only be carried out when the concentration-response functions of the two products are deemed statistically similar or parallel (Finney, 1964; Bortolotto et al., 2015).

Tech Briefing: ELISA and USP 1123.1 Interest Groups at BEBPA’s 2024 HCP Conference

The 2024 Host Cell Protein Conference will feature two Interest Groups on Day 3 which will be available only to in-person attendees. BEBPA conferences are well-known for their collegiality, opportunities for networking, and speakers/attendees who “tell it like it is,” and this is due in large part to conference Interest Groups and Workshops.

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 a suitable in-house RS is an important activity. As drug development proceeds, with possible changes in the manufacturing process and formulation, it usually proves necessary to replace an earlier RS with one that is representative of the current production or if stocks are running low. Most drug development programs require the establishment of a succession of RS, starting with a development RS (DRS), followed, as clinical trials start, by an interim RS (IRS) and then, ready for license submission, a primary RS (PRS) and working RS (WRS).

Tech Briefing: Use of Design of Experiment (DOE) for Bioassay Development

Doing more with fewer resources is the name of the game in any business. One of the best tools for cutting through the early stages of assay development, when one doesn’t know what assay parameters are critical and which aren’t, is the use of a multifactorial design of experiments (DOE). DOE allows assessment of multiple factors rather than the traditional “one-factor-at-a-time” (OFAT) approach.