Abstract
Host cell proteins (HCPs) are process-related impurities that may
co-purify with biopharmaceutical drug products. Within this class of
impurities there are some that are more problematic. These problematic
HCPs can be considered high-risk and can include those that are
immunogenic, biologically active, or enzymatically active with the
potential to degrade either product molecules or excipients used in
formulation, and often are difficult-to-purify. Why should the
biopharmaceutical industry worry about these high-risk host cell
proteins? What approach could be taken to understand the origin of this
co-purification and to deal with these high-risk HCPs? To answer these
questions, the BioPhorum Development Group (BPDG) HCP Workstream
initiated a collaboration among its 26-company team with the goal of
industry alignment around high-risk HCPs. A sub team was formed, in
which the members performed literature searches and discussed the
information available around this topic. A survey to the BPDG HCP
Workstream team members led to team discussions and insights into a list
of frequently seen problematic HCPs. These HCPs were further classified
based on their potential impact into different risk categories that
could be beneficial to the biopharmaceutical industry for targeted
monitoring of those HCP impurities in CHO-produced biologics to minimize
risk to product quality, safety, and efficacy.