BioPharmaceutical Emerging Best Practices Association
Category: Tech Briefing
The FDA has posted a request for information and comments in the Federal Register on the subject Evaluating the Immunogenicity…
The potency bioassay is a keystone assay supporting the regulatory quality assurance strategy for verifying that products released for commercial…
How good is good enough? As scientists we are trained to make our assays not just good but the best. However, sometimes…
The need for potency assays for biopharmaceutical therapeutics has been recognized for some time. The regulatory agencies from all ICH-abiding…
The 2024 Host Cell Protein Conference will feature two Interest Groups on Day 3 which will be available only to…
Volume 1, Issue 5: As potency of a biopharmaceutical product is determined by bioassay relative to a reference standard (RS),…
Doing more with fewer resources is the name of the game in any business. One of the best tools for…
Product Reference Material (RM) for determining potency of biopharmaceutical products is a critical manufacturing reagent. In a commercial environment a…
In this year’s BEBPA Host Cell Protein Conference, we are featuring presentations covering some recent successes downstream process engineers have…
The International Conference of Harmonization (ICH) just finalized two guidance documents which discuss analytical methods in depth: Q2(R2) Validation of…
In the “early days” of BEBPA HCP Conferences, there always seemed to be at least one public request for companies…
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The 2023 FDA Draft Guidance on Potency Assurance for Cellular and Gene Therapy Products makes the expectation clear that every…
Over the years we’ve heard more complaints about HCP ELISAs from gene and cell therapy folks than anyone else. Many of…
More than any other analytical method in the biopharmaceutical industry, the potency assay requires a in-depth knowledge of statistics. Most…
Volume 1, Issue 2: Dr. Denise Krawitz provided an excellent wrap up on the last day of BEBPA’s 11th Annual…
Host Cell Protein (HCP) analysis by mass spectrometry (LC-MS/MS) has obviously been growing in importance in the last decade. However,…
The FDA has two guidances about the potency of Cell and Gene Therapies (CGT). The most recent was released December…
Host cell proteins (HCPs) are a complex and diverse group of proteins produced by the cells used in biopharmaceutical manufacturing…
Potency bioassays are typically relative assays, meaning that the full dose-response curve of the reference is compared to the full…
Volume 1, Issue 1: Quality attributes of cell and gene therapy (CGT) products, also referred to as advanced therapy medicinal…
When the concept of “generic biotech products” (Biosimilars) was first introduced in the early 2000’s, many innovator companies confidently stated…
The first therapy using the CRISPR technology was approved in the UK on 21 November 2023, Casgevy (exagamglogene autotemcel) now…
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…
BEBPA Blog Survey Results for Bioassay Reference Standards-Feb 2021 (PDF) View the PDF below. View Technical Note
BEBPA Blog Outlier Analysis-May 2020 (PDF) View the PDF below. View Technical Note
BEBPA Blog Validating Potency Assays-Mar 2020 (PDF) View the PDF below. View Technical Note
BEBPA Blog Additional Studies Required for Potency Assays During Development-Feb 2020 (PDF) View the PDF below. View Technical Note
BEBPA Blog Impact of Product Mechanism of Action on Potency Assay Development-Jan 2020 (PDF) View the PDF below. View Technical…
BEBPA Blog Statistics for Validating Potency Assays-Aug 2019 (PDF) View the PDF below. View Technical Note
BEBPA Blog Primer on Dose-Response Curve Comparison in Potency Assays-Jul 2019 (PDF) View the PDF below. View Technical Note
BEBPA Blog Steps for Developing a Potency Assay-Jul 2019 (PDF) View the PDF below. View Technical Note
BEBPA Blog FDA Approves Two Gene Therapy Products – What Are the Potency Assays-Jun 2019 (PDF) View the PDF below.…
