Vaccine Potency Assays

We can support you in conducting potency assays of vaccines for quality control in order to substitute "in vivo" testing. We can develop and validate a new method from scratch or improve on pre-existing methods or commercial kits. We can transfer these methods to your lab or keep it in house to provide you routine quality control of batches under GMP.

In vitro potency assay for vaccines it is the best approach to have unexpensive and reliable quality control tests avoiding the use of experimental animals. The most extended methods are ELISA tests based on relevant antigen determination or activity determination by competitive immunoassay. We conduct the method validation following the ICH Q2 (R1). Once validated, we offer to transfer the methods to your lab or to keep them in our labs to provide you routine quality control of batches under GMP.

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We can manage alergy vaccines, recombinant vaccines or bacterial vaccines inactivated or up to biosafety class 2. KYMOS provides a full service which includes the obtention of polyclonal antibodies requiered through "in vivo" immunization of different species.

 

Other services for quality control of vaccines:

  • Antigen characterization
  • Adjuvant characterization
  • Determination of preservatives and other excipients
  • Characterization of In-House Reference Preparations (IHRP)
  • Stability studies of vaccines
  • Quality Control of batches

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