Host cell protein

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How to create a toolbox to assess your high-risk HCPs

Host cell proteins (HCPs) are process-related impurities derived from host cells that may co-purify with a biopharmaceutical drug product.   The detection, quantitation, and removal of HCPs from the final biotherapeutic process can be complex and some HCPs can be considered high-risk. They include those that are immunogenic, biologically active, or enzymatically active with the potential to degrade either product molecules or...

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“High-risk” host cell proteins (HCPs): A multi-company collaborative view

This database and paper provide a comprehensive review and list of potential problematic HCPs that could impact the safety, efficacy, and quality aspects of CHO-produced biologics during their development and manufacturing. They provide a reference on the best practice and control strategy for “high-risk” HCPs” in the biopharmaceutical industry.

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Development Group trends and new hot topics

Driven by the ever-increasing need to reduce product development lead times and the opportunities to exploit new technologies in development, BioPhorum Development Group (DG) has taken a detailed look at its portfolio of work and the work of its sponsors. This allowed it to reflect on where and how member companies are engaged. This was an important task and a very successful one and the Phorum is already seeing the impact in everything from...

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The BioPhorum and USP collaborative journey to new standards

BioPhorum and United States Pharmacopeia (USP) share a common direction – to accelerate biopharma innovation, quality and progress through collaboration. To this end, USP is engaging with industry to understand its pain points, its challenges and where there is the potential for new standards. “We have been looking at what additional standards we can develop that aren’t necessarily the traditional USP product-specific standards, but that would...

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Host cell protein (HCP): Risk assessment tool and papers

Host cell protein (HCP) constitutes a significant class of process-related impurities in biological drugs. The complexity and diversity of residual HCP composition in biologics and the incomplete understanding of their potential impact also pose unknown risks besides some of the well-known risks from certain problematic HCPs. This can make the HCP risk assessment and management an industry-wide challenge.

Although attempts have been made to address these challenges in the biopharmaceutical industry, gaps still remain in terms of how to manage the risks associated with HCP during bioprocess development. To this end, a BioPhorum Development Group (BPDG) HCP working team consisting of several companies initiated a collaboration among its members to align industry best practices and generated a generic risk assessment tool to manage HCP-related risks identified during biologics development from both an assay development and process development perspective.

Distinct from individual HCP identity-based safety risk assessment, this tool focuses on the manufacturing process through process development. The tool will help companies to tackle the risks associated with HCP within the development lifecycle. The intent the tool is to provide a template in order to guide process development teams using a scientific knowledge-based risk control strategy, where process or assay changes may be deemed necessary to reduce the risks caused by inadequate removal of HCP upon experimental studies to assess impact of HCPs on product safety, efficacy, and stability.

Companies implementing this risk management model can apply their own unique set of circumstances, products and experience to perform a more comprehensive and robust assessment of risk, identify the priority in which risk reduction steps should be applied.

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Host cell protein (HCP): A multi-company collaboration: Views on “high risk” HCP: Presentation

This presentation compliments the papers and risk manage tool. The goal of the Host Cell Protein (HCP) Workstream is to deliver for industry alignment; building a common understanding of agency requirements for HCPs through benchmarking and gap analysis of guidance. To widen understanding of the risks associated with HCPs and what can be done to mitigate these risks during process development. This poster available to ‘Members Only’ discusses, Industry benchmarking, understanding of what companies are doing in order to understand HCP risk through the stages of development, risk assessment methodology and risk scoring tool to perform qualitative and semi-quantitative assessment of risk when dealing with HCPs, case studies and next steps.

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