Host cell protein risk assessment, an industry approach
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 and therefore risks creates uncertainty for the industry, especially with known problematic HCPs. This in turn makes HCP risk assessment and management a common industry-wide challenge.
Although attempts have previously been made to address this situation, gaps still remain in dealing with the risks associated with HCPs during bioprocess development. To this end, the BioPhorum Development Group (BPDG) team, consisting of experts from several biopharmaceutical companies, have created a risk assessment tool that companies can use to help them manage the HCP-related risks identified during biologics development.
The team have written a two-part article which describes their approach in detail. The first part has just been published in BioProcess International and can be accessed through the BioPhorum website here or directly through the journal.