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Stability Studies

Drug substance and drug product stability studies performed according to ICH guidelines to support your clinical product.

At Vibalogics we offer a comprehensive set of stability indicating tests, including identity, purity, physico-chemical and cell-based potency assays, so that we can work together with you to design a stability package that meets your requirements and the expectations of the regulatory authorities.

Vibalogics offers:

  • Long term stability studies according to ICH Q1A guidelines
  • Accelerated temperature studies
  • Certificate of Analysis provided at each time point
  • Stability plan determined in conjunction with customer requirements
  • Final report provided at the end of the study

We offer this service either as part of a manufacturing project, or as a stand-alone study. Speak to us today about your requirements and we will be happy to provide you with a solution.

For more information regarding Virus Stability Studies, contact us today on +49 4721 565 400 or email contact@vibalogics.com

Cell Based Virus

Comprehensive service for viral products…

…including viral vaccines, gene therapies and oncolytic virotherapies