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),…
Read more
As part of BEBPA’s mandate to provide forums to foster scientific discussion among biopharmaceutical scientists, we actively write up the results of these discussions. These written updates come in the form of White papers written by a committee of scientists, the results of live interactive surveys and occasionally written reports by attendees. These reports are made available to the public and can be downloaded freely.
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…
2024 USB Conference Survey Results (PDF)
BEBPA Blog 2024 US Bioassay Survey Results (pdf) View the PDF below. View Survey Results
Reference Standards for Accurate Validation and Optimization of Assays
BEBPA Blog Reference Standards for Accurate Validation and Optimization of Assays This article was referenced in Dr. Zhiyong He, Biologist,…
Before the Beginning Comes the Question: A Journey Through the Statistical Fundamentals of Comparability
Volume 1, Issue 4: Complex biopharmaceutical processes often require changes to satisfy production scaling, cost optimization, product safety and efficacy,…
Mini History of the Potency Bioassay and its Regulatory Drivers
Volume 1, Issue 3: The concept of potency assays came into being specifically for biopharmaceutical products. Originally, these products were…
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,…
2023 Ref Material Free Webinar Survey Results (PDF)
BEBPA Blog 2023 Ref Material Free Webinar Survey Results (PDF) View the PDF below. View Survey Results
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…
2023 EUB Conference Survey Results (PDF)
BEBPA Blog 2023 EUB Conference Survey Results (PDF) View the PDF below. View Survey Results
2023 EUB Workshop Survey Results (PDF)
BEBPA Blog 2023 EUB Workshop Survey Results (PDF) View the PDF below. View Survey Results
2023 EUB Interest Group Survey Results (PDF)
BEBPA Blog 2023 EUB Interest Group Survey Results (PDF) View the PDF below. View Survey Results
2023 HCP Conference Survey Results (PDF)
BEBPA Blog 2023 HCP Conference Survey Results (PDF) View the PDF below. View Survey Results
2023 USB Conference Survey Results (PDF)
BEBPA Blog 2023 USB Conference Survey Results (PDF) View the PDF below. View Survey Results
2022 EUB Conference Survey Results (PDF)
BEBPA Blog 2022 EUB Conference Survey Results (PDF) View the PDF below. View Survey Results
2022 EUB Workshop-2 Survey Results (PDF)
BEBPA Blog 2022 EUB Workshop-2 Survey Results (PDF) View the PDF below. View Survey Results
2022 HCP Conference Survey Results (PDF)
BEBPA Blog 2022 HCP Conference Survey Results (PDF) View the PDF below. View Survey Results
2022 USB Conference Survey Results (PDF)
BEBPA Blog 2022 USB Conference Survey Results (PDF) View the PDF below. View Survey Results
2021 EUB Conference Survey Results (PDF)
BEBPA Blog 2021 EUB Conference Survey Results (PDF) View the PDF below. View Survey Results
2021 HCP Conference Survey Results (PDF)
BEBPA Blog 2021 HCP Conference Survey Results (PDF) View the PDF below. View Survey Results
2021 USB Conference Survey Results (PDF)
BEBPA Blog 2021 USB Conference Survey Results (PDF) View the PDF below. View Survey Results
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.…
2018 Host Cell Protein Analysis in Biologic Drug Development – BioAnalytix (PDF)
BEBPA Blog 2018 Host Cell Protein Analysis in Biologic Drug Development – BioAnalytix (PDF) View the PDF below. View White…
2017 Use of DOE for Bioassay Development (PDF)
BEBPA Blog 2017 Use of DOE for Bioassay Development (PDF) View the PDF below. View White Paper
Assay Acceptance Criteria for Multiwell-Plate–Based Biological Potency Assays (PDF)
Product reference standards (RS) are critical for nearly all analytical assays used to release commercial biotech products. Potency assays are…
2014 Assay Acceptance Criteria for Multiwell-Plate–Based Biological Potency Assays (Draft for Consultation)
BEBPA Blog 2014 Assay Acceptance Criteria for Multiwell-Plate–Based Biological Potency Assays (Draft for Consultation) View the PDF below. View White…
2013: HCP Testing, Some Points to Consider by Martin Vanderlaan (PDF)
BEBPA Blog White Paper: 2013: HCP Testing, Some Points to Consider by Martin Vanderlaan (PDF) View the PDF below. View…
2020 EUB Conference Survey Results (PDF)
BEBPA Blog 2020 EUB Conference Survey Results (PDF) View the PDF below. View Survey Results
2020 HCP Conference Survey Results (PDF)
BEBPA Blog 2020 HCP Conference Survey Results (PDF) View the PDF below. View Survey Results
2020 USB Conference Survey Results (PDF)
BEBPA Blog 2020 USB Conference Survey Results (PDF) View the PDF below. View Survey Results
Shiaw-Lin (Billy) Wu, PhD, Chief Scientific Officer, Bioanalytix
BEBPA Blog Shiaw-Lin (Billy) Wu, PhD, Chief Scientific Officer, Bioanalytix 2019 BEBPA HCP Conference Speaker Title: Advanced LC-MS Approach for Characterization…
2019 EUB Conference Survey Results (PDF)
BEBPA Blog 2019 EUB Conference Survey Results (PDF) View the PDF below. View Survey Results
2019 HCP Conference Survey Results (PDF)
BEBPA Blog 2019 HCP Conference Survey Results (PDF) View the PDF below. View Survey Results
2018 EUB Conference Survey Results – Use of QbD and DOE Tools for BioAssay Development (PDF)
BEBPA Blog 2018 EUB Conference Survey Results – Use of QbD and DOE Tools for BioAssay Development (PDF) View the…
2017 EUB Conference Survey Results – Reportable Values for Potency Assay (PDF)
BEBPA Blog 2017 EUB Conference Survey Results – Reportable Values for Potency Assay (PDF) View the PDF below. View Survey…
2015 HCP Conference Survey Results (PDF)
BEBPA Blog 2015 HCP Conference Survey Results (PDF) View the PDF below. View Survey Results
2014 EUB Conference Survey Results – Validation Summary (PDF)
BEBPA Blog 2014 EUB Conference Survey Results – Validation Summary (PDF) View the PDF below. View Survey Results
2008 EUB Conference Survey Results – Bioassays in the Biopharmaceutical Industry (PDF)
BEBPA Blog 2008 EUB Conference Survey Results – Bioassays in the Biopharmaceutical Industry (PDF) View the PDF below. View Survey…
