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),…
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Category: Tech Briefing
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…
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…
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…
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…
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…
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…
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The 2023 FDA Draft Guidance on Potency Assurance for Cellular and Gene Therapy Products makes the expectation clear that every…
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…
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…
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…
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,…
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…
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…
Tech Briefing: Dealing with the Intricacies of Potency Assay Dose-Response Curves
Potency bioassays are typically relative assays, meaning that the full dose-response curve of the reference is compared to the full…
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…
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…
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…
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,…
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…
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…
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…
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…
Survey Results for Bioassay Reference Standards-Feb 2021 (PDF)
BEBPA Blog Survey Results for Bioassay Reference Standards-Feb 2021 (PDF) View the PDF below. View Technical Note
Outlier Analysis-May 2020 (PDF)
BEBPA Blog Outlier Analysis-May 2020 (PDF) View the PDF below. View Technical Note
Validating Potency Assays-Mar 2020 (PDF)
BEBPA Blog Validating Potency Assays-Mar 2020 (PDF) View the PDF below. View Technical Note
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 the PDF below. View Technical Note
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 the PDF below. View Technical…
Statistics for Validating Potency Assays-Aug 2019 (PDF)
BEBPA Blog Statistics for Validating Potency Assays-Aug 2019 (PDF) View the PDF below. View Technical Note
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 the PDF below. View Technical Note
Steps for Developing a Potency Assay-Jul 2019 (PDF)
BEBPA Blog Steps for Developing a Potency Assay-Jul 2019 (PDF) View the PDF below. View Technical Note
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 the PDF below.…
