BioPharmaceutical Emerging Best Practices Association

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Tech Briefing: In‑Person Expertise Matters: Building Depth in HCP Analytics at the 2026 BEBPA HCP Workshop

In an era when AI tools can surface information within seconds, the challenge is no longer access, but the ability to critically evaluate it, interpret it, and place it in the context of real-world analytical challenges. This is especially true in HCP analysis, where no single individual – regardless of expertise – can realistically maintain deep, up-to-date knowledge across all aspects of immunoassay technologies, LC-MS workflows, coverage assessment strategies, regulatory considerations, and emerging modality-specific HCP risks. The breadth and complexity of the field make collective experience essential.

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. 

Unveiling Host Cell Protein (HCP) Coverage in Three-Dimensions (3D): Why It Matters and How to Achieve It

Host cell proteins (HCPs) are impurities derived from the host organism used in the production of genetically engineered biopharmaceuticals. Their removal is crucial for the safety and efficacy of the final product, as they can provoke unwanted immune responses and/or have undesired biological/enzymatic activities[1-4]. The sandwich enzyme-linked immunosorbent assay (ELISA) remains the most widely used method for HCP quantification throughout biopharmaceuticals product development lifecycle due to its high sensitivity, throughput, and selectivity in complex sample matrices.

Tech Briefing: Beyond the Surface: Is Going Deeper Always More Beneficial?

Host cell proteins (HCPs) are residual protein impurities expressed along with the desired biologics product. Removing HCPs in the final drug substance (DS) to an acceptable level sometimes can be challenging because of the diverse nature of the HCPs and their potential affinity for the intended product, especially for non-monoclonal antibody (non-mAb) products due to the lack of affinity purification process.

Critical HCPs: What to do with them?

Volume 1, Issue 9: Host cell proteins (HCPs) are a complex blend of various proteins that need to be depleted during the production of biotherapeutics. Any residual HCPs can pose diverse risks to quality, safety, and developability of a drug. There is manufacturing and clinical history indicating certain classes of HCPs which have been problematic, e.g. HCPs which,

Host Cell Proteins Remain a Hotly Debated and Emerging Topic

Volume 1, Issue 8: At the finish of the recent 12th annual Host Cell Protein Conference (May 14-16, 2024) sponsored by BEBPA in College Park, MD, Dr. Denise Krawitz gave her final summary of conference highlights. We thought it would be fun and informative for those of you who could not join us to hear a synopsis of the 3-day conference from her perspective. Below you will find excerpts from her summary:

Tech Briefing: ELISA and USP 1123.1 Interest Groups at BEBPA’s 2024 HCP Conference

The 2024 Host Cell Protein Conference will feature two Interest Groups on Day 3 which will be available only to in-person attendees. BEBPA conferences are well-known for their collegiality, opportunities for networking, and speakers/attendees who “tell it like it is,” and this is due in large part to conference Interest Groups and Workshops.

Tech Briefing: Improved Clearance of High Risk HCPs

In this year’s BEBPA Host Cell Protein Conference, we are featuring presentations covering some recent successes downstream process engineers have had in in improving the purity of biopharmaceuticals.