2024 EUB Conference Survey Results (PDF)
BEBPA Blog 2024 EUB Conference Survey Results (PDF) View the PDF below. View Survey Results
Read more
Category: Bioassay
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…
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…
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…
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: 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,…
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The 2023 FDA Draft Guidance on Potency Assurance for Cellular and Gene Therapy Products makes the expectation clear that every…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: 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…
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: 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…
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…
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…
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 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 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 USB Conference Survey Results (PDF)
BEBPA Blog 2021 USB Conference Survey Results (PDF) View the PDF below. View Survey Results
2020 EUB Conference Survey Results (PDF)
BEBPA Blog 2020 EUB 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
2019 EUB Conference Survey Results (PDF)
BEBPA Blog 2019 EUB 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…
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…
