Precision Control of HCP Residuals, Safeguarding the Quality and Safety of Biologics Throughout Their Lifecycle

In the R&D and manufacturing of biologics, Host Cell Protein (HCP) residuals represent a Critical Quality Attribute (CQA) that determines the safety, efficacy, and regulatory compliance of drug products. As trace impurities unavoidable in production, HCPs may induce immunogenic responses, reduce drug stability, and impact product potency. They are therefore a core quality control focus for regulatory authorities and pharmaceutical companies worldwide.

Following the implementation of the Chinese Pharmacopoeia 2025 Edition, together with the release of ICH Q6B and USP <1132> guidelines, HCP testing has evolved from total‑quantity control to a new stage of precision identification + risk stratification. Establishing a scientific, compliant, and efficient HCP residual testing system has become an essential capability for biologics throughout process development, clinical filing, and commercial release.

Why HCP Residuals Are a “Must‑Answer” Question in Biologics QC

Mainstream HCP Detection Technologies: From Standard Methods to Orthogonal Strategies

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