Despite ongoing process improvements in manufacturing, Host cell protein (HCP) process impurities remain a substantial risk for biological products. Even at low levels, residual HCPs can induce a detrimental immune response, compromising the safety and efficacy of a biologic. Consequently, advanced-stage clinical trials have been cancelled due to the identification of antibodies against HCPs. From a safety, efficacy and regulatory standpoint, the presence of these impurities should be assessed and addressed early in the product characterization process.
As a solution, EpiVax has developed an efficient, internet-based interface for immunogenicity screening of host cell proteins. The Interactive Screening and Protein Reengineering Interface for Host Cell Proteins (ISPRI-HCP) is a secure, online work environment, supported by EpiVax’s proprietary EpiMatrix and JanusMatrix algorithms and can be used to evaluate the immunogenic potential of contaminant Chinese Hamster Ovary (CHO) proteins.
CHO cell lines are commonly used in the manufacturing of protein therapeutics and, despite mammalian origin, CHO contaminants can still present a significant immunogenicity risk. Fortunately, because CHO proteins are mammalian in origin, many of the epitopes found in CHO contaminants are similar to those found in human proteins and thus less likely to drive an adverse immune response. By utilizing T cell cross-reactivity analysis from JanusMatrix, the ISPRI-HCP tool can identify the number of more dangerous CHO-unique epitopes found within a potential contaminant.
Application of the ISPRI-HCP tool can help to enhance the quality and value of your biomanufacturing processes, serving as computational complement to existing experimental approaches for the assessment of risk associated with HCP process impurities.