Lot & Final Drug Product Release Testing

Charles River provides release testing services for bulk drug substances and clinical and marketed products for the European Union (EU), United States (US) and other regulatory-distinct markets, and can act as a single site for your global release testing.

Our highly experienced team is committed to successful long-term relationships with our product release clients. We have gained valuable experience over the past 15 years generating data in support of more than 8,000 batches of various protein and small molecule products. Each year, we perform full specification release tests on over 500 batches of 22 final products and single tests on many more. We work closely with operational staff, offering flexibility to meet clients' manufacturing schedules.

Release Testing Requirements

  • Identity
  • Potency
  • Purity and impurities
  • Physicochemical properties
  • Presentation attributes
  • Sterility

If you need the results of your testing expedited, Fast Track Testing is available for our mycoplasma, sterility and adventitious virus testing assays. Learn more »

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European Lot Release Testing

This webinar provides information on the regulations governing European importation testing for pharmaceutical products and the need for Quality Agreements governing these activities.