BEBPA Blog
Category: White Papers
Reference Standards for Potency Assays: White Paper
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
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 White Paper
2017 Use of DOE for Bioassay Development (PDF)
BEBPA Blog 2017 Use of DOE for Bioassay Development (PDF) View PDF Survey
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 usually relative potency assays, meaning
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 White Paper
2013: HCP Testing, Some Points to Consider by Martin Vanderlaan (PDF)
BEBPA Blog 2013: HCP Testing, Some Points to Consider by Martin Vanderlaan (PDF) View PDF Survey