Complex ChemistryPolymer/NanoparticlesAnalytical Method DevelopmentFormulation DevelopmentProcess Development

Analytical Method
Development

Reliable methods to characterize your product

Accelerating your path to the clinic and beyond, we develop, execute and document phase appropriate methods necessary to produce quality, well-characterized material, and data to support successful IND and marketing applications as you move towards commercialization.

Applying our experience, we develop data packages that support your regulatory approvals with all global agencies.

To create a robust product development program and accelerate your timelines we leverage our comprehensive in-house capabilities, technologies, and knowledge to deliver methods tailored to your molecule of interest.

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Our Approach

Our approach focuses on developing and qualifying phase appropriate assays for a spectrum of safety, potency, purity, identity, and extended characterization that enables end-to-end support for:

  • Process characterization
  • Process development
  • Formulation development
  • GMP manufacturing
  • Release and stability testing for GMP material

Our Methods

Our global team of expert analytical scientists develop analytical test methods and qualification protocols, tailored to your needs. Methods can also be developed de novo or transferred in from external laboratories.

By understanding your molecules’ attributes, we support future development activities with customized characterization assays.

Once methods are established, we optimize and refine them for the molecule of interest as part of an integrated service that supports process and formulation development for bioconjugation.