BEBPA Blog
Category: Tech Briefing
Tech Briefing: Beyond the Surface: Is Going Deeper Always More Beneficial?
Host cell proteins (HCPs) are residual protein impurities expressed along with the desired biologics product. Removing HCPs in the final drug substance (DS) to an
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
Tech Briefing: The Wonderful World of Automation and Artificial Intelligence in the Bioassay Lab
At BEBPA we track implementation of new technologies, analysis approaches and the emergence of new technologies in the potency bioassay world. Over the past years,
Tech Briefing: Want to Question Authority? Develop a Bioassay!
A hallmark of a potency bioassay is that it is guaranteed to be different from any bioassay ever developed previously….or is it? (Ah here we
Tech Briefing: Bioassay for Complex Products: You have come a long way, baby.
Remember when a monoclonal antibody (mAb) was considered a “complex” product? A mere 30 years ago! As we gained experience with these molecules, we transitioned
FDA Federal Register: Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products
The FDA has posted a request for information and comments in the Federal Register on the subject Evaluating the Immunogenicity Risk of Host Cell Proteins
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
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
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
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
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
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
Tech Briefing: Reference Material (RM) For Determining Potency of Biopharmaceutical Products
Product Reference Material (RM) for determining potency of biopharmaceutical products is a critical manufacturing reagent. In a commercial environment a company allows their product RM
Tech Briefing: Improved Clearance of High Risk HCPs
In this year’s BEBPA Host Cell Protein Conference, we are featuring presentations covering some recent successes downstream process engineers have had in in improving the
Tech Briefing: Developing Potency Assays to Support Early Phase Clinical Studies
The International Conference of Harmonization (ICH) just finalized two guidance documents which discuss analytical methods in depth: Q2(R2) Validation of Analytical Procedures Guidance for Industry
Tech Briefing: Pooling Industry-Wide Data for Determining Relevant HCPs
In the “early days” of BEBPA HCP Conferences, there always seemed to be at least one public request for companies to disclose information about HCPs
Tech Briefing: The Wonderful World of Potency Assays: Look at me now Ma!
The concept of potency assays came into being specifically for biopharmaceutical products. Originally these products were complex mixtures, produced in a natural system (Like a
Tech Briefing: Forced Degradation for CGT Products
The 2023 FDA Draft Guidance on Potency Assurance for Cellular and Gene Therapy Products makes the expectation clear that every lot of drug product (DP)
Tech Briefing: HCP ELISAs for Gene Therapy Products
Over the years we’ve heard more complaints about HCP ELISAs from gene and cell therapy folks than anyone else. Many of the developmental efforts have
Tech Briefing: Ins and Outs of Data Analysis for Potency Calculations
More than any other analytical method in the biopharmaceutical industry, the potency assay requires a in-depth knowledge of statistics. Most potency assays are cell-based relative
Synopsis: BEBPA’s 2023 Host Cell Protein Conference in Review
Volume 1, Issue 2: Dr. Denise Krawitz provided an excellent wrap up on the last day of BEBPA’s 11th Annual HCP Conference held in May
Tech Briefing: Mass Spectrometry In HCP Analysis (USP 1132.1)
Host Cell Protein (HCP) analysis by mass spectrometry (LC-MS/MS) has obviously been growing in importance in the last decade. However, LC-MS/MS analysis is generally used
Tech Briefing: FDA Guidances for Assessing and Assuring the Potency of Cell and Gene Therapy Products
The FDA has two guidances about the potency of Cell and Gene Therapies (CGT). The most recent was released December 2023 entitled Potency Assurance for
Tech Briefing: Working with Host Cell Proteins
Host cell proteins (HCPs) are a complex and diverse group of proteins produced by the cells used in biopharmaceutical manufacturing processes. We’d like to think
Technical and Regulatory Considerations for Cell and Gene Therapy Raw Materials
Volume 1, Issue 1: Quality attributes of cell and gene therapy (CGT) products, also referred to as advanced therapy medicinal products (ATMPs) in the EU,
Tech Briefing: Potency Assays for Biosimilar Products
When the concept of “generic biotech products” (Biosimilars) was first introduced in the early 2000’s, many innovator companies confidently stated that it would never happen.
Considerations for manufacturing ex-vivo therapeutic products: CRISPR, Cell Sourcing, Potency and Beyond
The first therapy using the CRISPR technology was approved in the UK on 21 November 2023, Casgevy (exagamglogene autotemcel) now has a conditional authorization from
Tech Briefing: Ins and Outs of Data Analysis
Establishing a potency assay to release a biopharmaceutical product is challenging in that we are attempting to harness biology (cells, enzymes, biomarkers, etc) to give
Tech Briefing: Improving the Bioassay Experience
If you are in the trenches trying to understand the Mechanism of Action of your drug product (DP), gathering the biological reagents and generating a
Product Potency Standards Throughout The Life Cycle of the Potency Assay
The determination of the potency of the RS throughout a product’s lifecycle needs to be accurate, precise, reliable, and consistent across time and across multiple
Reference Material for Late Stage Potency Assay Development
Reference material is a critical reagent for nearly all CMC release assays for biotherapeutic products. Potency assays are particularly reliant upon the use of a
How Much Can We Reduce The Complexity of Bioassays?
In some respects, the key to developing a robust and reliable potency assay is all about simplification. If the biology is simplified, the reagents characterized
Survey Results for Bioassay Reference Standards-Feb 2021 (PDF)
BEBPA Blog Survey Results for Bioassay Reference Standards-Feb 2021 (PDF) View PDF Survey
Outlier Analysis-May 2020 (PDF)
BEBPA Blog Outlier Analysis-May 2020 (PDF) View PDF Survey
Validating Potency Assays-Mar 2020 (PDF)
BEBPA Blog Validating Potency Assays-Mar 2020 (PDF) View PDF Survey
Additional Studies Required for Potency Assays During Development-Feb 2020 (PDF)
BEBPA Blog Additional Studies Required for Potency Assays During Development-Feb 2020 (PDF) View PDF Survey
Impact of Product Mechanism of Action on Potency Assay Development-Jan 2020 (PDF)
BEBPA Blog Impact of Product Mechanism of Action on Potency Assay Development-Jan 2020 (PDF) View PDF Survey
Statistics for Validating Potency Assays-Aug 2019 (PDF)
BEBPA Blog Statistics for Validating Potency Assays-Aug 2019 (PDF) View PDF Survey
Primer on Dose-Response Curve Comparison in Potency Assays-Jul 2019 (PDF)
BEBPA Blog Primer on Dose-Response Curve Comparison in Potency Assays-Jul 2019 (PDF) View PDF Survey
Steps for Developing a Potency Assay-Jul 2019 (PDF)
BEBPA Blog Steps for Developing a Potency Assay-Jul 2019 (PDF) View PDF Survey
FDA Approves Two Gene Therapy Products – What Are the Potency Assays-Jun 2019 (PDF)
BEBPA Blog FDA Approves Two Gene Therapy Products – What Are the Potency Assays-Jun 2019 (PDF) View PDF Survey