Stability Panel Discussion
BEBPA Blog Stability Conference Panel Discussion Question: Andrew Lennard: It was more of an attempt to explain how the ICH consensus technical document arrived at
2025 Stability Conference Survey Results (PDF)
BEBPA Blog 2025 Stability Conference Survey Results (PDF) View PDF Survey
2025 Halloween Horrors Survey Results (PDF)
BEBPA Blog 2025 Halloween Horrors Survey Results (PDF) View PDF Survey
Characterization of Critical Reagents for HCP ELISA Development by Orthogonal Methods
Volume 2, Issue 8: The development of host cell protein enzyme-linked immunosorbent assays (HCP ELISAs) requires comprehensive analytical characterization of the critical ELISA reagents including the HCP mock material and anti-HCP antibodies by different orthogonal methods (as described in USP 1132[1]).
2025 EUB Conference Survey Results (PDF)
BEBPA Blog 2025 EUB Conference Survey Results (PDF) View PDF Survey
Tech Briefing: It all happens in Bioassay Development: Regulatory Expectations, Scientific Rationale, Artificial Intelligence and Technology
Artificial intelligence and automation are popular across many different industries including potency assay development. After all why should we, development scientists, do manual work ourselves if we can delegate it to a machine and get better, faster results.
Unlocking the Multifaceted Mechanisms of Antibody–Drug Conjugates
Volume 2, Issue 7: Antibody–drug conjugates (ADCs) represent a promising frontier in targeted cancer therapy, marrying the specificity of monoclonal antibodies with the potent cell-killing capabilities of cytotoxic drugs. As complex bioconjugates, ADCs use multifaceted and multistep mechanisms of action (MOA) to deliver their therapeutic payloads precisely to tumor cells. In recent years, the clinical landscape has witnessed an accelerated development and approval of ADCs, reflecting both their innovative design and the expanding understanding of their molecular intricacies. Approved ADCs deploy a variety of MOAs—including direct cytotoxicity, bystander killing, receptor blockade, and internalization—while also engaging immune-mediated processes such as antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement-dependent cytotoxicity (CDC) (1). Looking ahead, next-generation payloads aim to broaden this therapeutic arsenal by incorporating immune modulation, altering protein expression, and directly targeting specific oncogenic mutations.
2025 BEBPA HCP Conference Review
I want to express my thankfulness to those of you who attended and participated in the 2025 BEBPA HCP Conference in Bled, Slovenia. We had a wonderful environment and atmosphere at this conference. Being in such a lovely yet simple setting added to the friendliness and collegiality of the event. I am biased, but I cannot remember being at a conference where the attitude and spirit was so open and pleasant. The scientific and engineering content of the conference was also invigorating and fostered open discussions about the challenges in our field.
2025 HCP Conference Survey Results (PDF)
BEBPA Blog 2025 HCP Conference Survey Results (PDF) View PDF Survey
Tech Briefing: Relative Potency Assays: Parallel Line vs. Slope Ratio Assays
Although the potency bioassay is considered a critical analytical method, finding regulatory guidelines which answer practical questions can be difficult. The pharmacopeia, USP and EP have the most prescriptive documents.