Development 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.
Materials to provide
- Information about the project
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- Specific HCP-ELISA
- Supply risk management
- Study following the specifications validated with the Expert
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