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Your product development program will be accelerated by leveraging our extensive in-house analytical capabilities, technologies, and knowledge to deliver methods tailored to your molecule of interest.
Get in touchAccelerating your path to the clinic, we develop, execute and document phase appropriate methods necessary to produce high-quality, well-characterized material and the data to support successful IND and marketing applications as you move towards commercialization.
Applying our expertise and experience, we develop data packages that support your regulatory approvals with all global agencies.
Our Approach
Our approach focuses on developing and qualifying phase appropriate assays for a spectrum of safety, potency, purity, identity, and extended characterization that enable end-to-end support for:
Our global team of expert analytical scientists develop analytical test methods and analytical qualification protocols, leveraging state-of-the-art instrumentation and a molecule-specific, customized approach to method development, qualification, and testing.
Methods can be developed de novo or transferred in from external laboratories.
Once methods are established, we optimize and refine them for the molecule of interest as part of an integrated service that supports cell line, process, and formulation development, and/or bioconjugation.
We leverage our expansive in-house capabilities, technologies, and molecule-specific methods to create a customized approach to method development ensuring your overall success in delivering vital medicines to patients.
