Developement of process-specific HCP ELISA
The development of a process-specific HCP ELISA HCP is recommended either, if no generic kit is suitable for bio-production, or for bioprocesses in advanced clinical phases. The advantage of quantifying HCPs with a specific process ELISA is multiple: anti-HCP antibodies have been specifically generated for this bio-production and therefore have a better coverage rate ; the HCP standard is fully adapted to the bio-production process ; mastery of supply chain management ; transfer to an ELISA in ready-to-use kit format ; validation of its stability and validation according to ICHQ2R1 guidance are also possible.
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