BEBPA Blog
Category: Reference Material
Virtual Reference Material Conference: Your Questions Answered
Thank you to those that attended BEBPA’s Virtual Reference Material Conference in June 2024. Due to time limitations there were some unanswered questions at the
2024 Reference Material Conference Survey Results (PDF)
BEBPA Blog 2024 Reference Material Conference Survey Results (PDF) View PDF Survey
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: 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
Reference Standards for Accurate Validation and Optimization of Assays
This article was referenced in Dr. Zhiyong He, Biologist, NIST, at the 2024 US Bioassay Conference. Link to the publication below.
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
2023 Ref Material Free Webinar Survey Results (PDF)
BEBPA Blog 2023 Ref Material Free Webinar Survey Results (PDF) View PDF Survey
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