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Developement of process-specific HCP ELISA

Bioprocess Quality control Developement of process-specific HCP ELISA

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

Further details on the project may be requested directly by the expert. You will be able to exchange directly with the experts after filling in the form below.

Delivrable(s)

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

Your project

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