It is impossible to define the raw materials used in the biopharmaceutical industry with a single set of regulatory or compliance criteria. What is considered fit-for-function changes depending on the product attributes and the intended customer. This tool standardizes and structures the risk assessment process, addressing three fundamental questions when determining raw material fit-for-function: What user requirement is the raw material designated to perform? What material attributes are essential to the designated function and what might have unintended consequences? This paper helps improve communication between – and within – manufacturers and suppliers and enables users to make uniform, evidence-based decisions on risks and priorities concerning raw materials. An industry-wide methodology for the resolution of high-impact raw material variability issues.
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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.
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.