Development of process-specific HCP ELISA

37.1 -Production-Par-Bacteries

Service description

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

    Further details on the project may be requested.

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Typical deliverables

  • Specific HCP-ELISA
  • Supply risk management
  • Study following the specifications validated with the Expert

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