Everything You Wanted to Know About Replacing Your HCP Method – But Were Afraid to Ask

David Meraro, Analytical R&D, Protalix Biotherapeutics, Carmiel, Israel (dudim@protalix.com)

What happens when you discover that your existing HCP (Host Cell Protein) assay is no longer meets regulatory expectations or analytical requirements? How do you choose the right strategy for developing a new method, ensure that it truly reflects the real HCP profile, and will be accepted by regulatory authorities?

The presentation will describe a real case study in which a new ELISA method had to be developed to meet updated regulatory guidelines. Two ELISA assays developed in parallel produced completely different results, raising the challenge of determining which one was most suitable. Using mass spectrometry (MS) profiling, the team was able to map and characterize the differences and identify the preferred method. However, the results obtained diverged significantly from those generated by the original assay, creating a regulatory dilemma.

The lecture will discuss the analytical, technical, and regulatory considerations involved in resolving such discrepancies and outline a practical approach to align scientific data with regulatory expectations during HCP method replacement.Enter the body of your abstract here