STRATEGY
Challenges and Solutions in HCP ELISA Development B The importance of reliable Host Cell Protein (HCP) monitoring during manufacturing of biopharmaceutical drugs In this article we will discuss regulatory recommendations concerning the determination of process-related impurities during biopharmaceutical drug manufacturing. Furthermore, we suggest their implementation into the setup of a reliable Host Cell Protein (HCP) monitoring using Enzyme-linked Immunosorbent Assay (ELISA) during early and late stages and provide valuable insights into critical steps along the way of HCP ELISA setup. Martin Fรถge, Business Development Manager, BioGenes
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P H A RM A F O C U S A S I A
ISSUE 41 - 2020
iopharmaceutical drugs make up a large portion of global pharma sales, with 8 of the top 10 global drug blockbusters in 2019 being recombinant biopharmaceuticals. Drug development is separable into five phases: i) Pre-clinical Phase, ii) Clinical Trials Phase I, iii) Clinical Trials Phase II, iv) Clinical Trials Phase III, and v) the Market Authorisation Application (MAA) followed by the Drug Launch, after all previous steps have been passed successfully. To ensure high-level patient safety during Clinical Trials and upon drug product release, a multitude of regulations have been authored by different regulatory bodies, such as the US FDA and the EMA. The MAA requires a profound overall assessment of potential risks and benefits, the so-called Critical Quality Attributes (CQA), which are included in the Common Technical Document (CTD). Host Cell Proteins (HCP) are one such CQA, they stem from the production cell line used for biological product manufacturing. Defined as process-related drug impu-
