BioGenes said that the results confirmed the observation of several contract manufacturers that generic HCP assays are only of limited use for detection of HCPs during manufacturing processes. The continued use of generic HCP assays may lead to insufficient process documentation and finally to safety hazards for patients.
Generic HCP assays are commercially available and often used to minimise the costs of the sponsor in early phases of clinical development when the risk of drug failure is still high. They are used alongside the manufacturing process to monitor HCP-related impurities. As the development of highly sensitive process-specific HCP assays is associated with higher costs, such assays are usually not initiated until proof-of-concept.
Alexander Knoll, managing director at BioGenes, said: “Our study results show that the generic HCP assay for CHO cells didn’t perform as specified. Among five process-specific HCP assays that we have tested, one assay showed comparable and two showed even better performance than the generic assay, although the assays were developed for a specific process.
“The generic assay’s limitation also became obvious when we applied it to several HCP preparations. With one HCP standard only 20% of the proteins could be detected. With the other HCP standards 40% and 25% of the proteins were detected, respectively. For a generic assay intended to recognize a broad HCP population, we would have expected recovery rates above 70%.”