Analytical Methods Development

Passion for your process, product and patients

The development of robust, accurate, precise and specific analytical methods to reliably establish the identity, purity, potency and safety of your biological product is critical for the production of a safe and effective treatment for your patients.

We understand that your product has distinct properties, as well as those common to other biologics. As a Therapure client, you will benefit from our experienced analytical development team that will either optimize your established methods or develop new methods to support your custom product development program.

Our analytical development team works closely with our quality control department to develop cGMP-compliant analytical and testing methodologies for in-process analysis, drug substance release, drug product release and stability studies.

Capabilities and services

  • Protein characterization (recombinant proteins and antibodies)
  • Complex biological activity assays
  • Physiochemical analysis
  • Blood/plasma protein assays