BEBPA Blog

Doing more with fewer resources is the name of the game in any business. One of the best tools for…

The International Conference of Harmonization (ICH) just finalized two guidance documents which discuss analytical methods in depth: Q2(R2) Validation of…

The concept of potency assays came into being specifically for biopharmaceutical products. Originally these products were complex mixtures, produced in…

The 2023 FDA Draft Guidance on Potency Assurance for Cellular and Gene Therapy Products makes the expectation clear that every…

More than any other analytical method in the biopharmaceutical industry, the potency assay requires a in-depth knowledge of statistics. Most…

The FDA has two guidances about the potency of Cell and Gene Therapies (CGT). The most recent was released December…

Potency bioassays are typically relative assays, meaning that the full dose-response curve of the reference is compared to the full…

When the concept of “generic biotech products” (Biosimilars) was first introduced in the early 2000’s, many innovator companies confidently stated…

Establishing a potency assay to release a biopharmaceutical product is challenging in that we are attempting to harness biology (cells,…

If you are in the trenches trying to understand the Mechanism of Action of your drug product (DP), gathering the…

The determination of the potency of the RS throughout a product’s lifecycle needs to be accurate, precise, reliable, and consistent…

Reference material is a critical reagent for nearly all CMC release assays for biotherapeutic products. Potency assays are particularly reliant…

In some respects, the key to developing a robust and reliable potency assay is all about simplification. If the biology…