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Bioconjugate
Analytical Method
Development

Reliable methods to characterize your product

Ensuring 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 focuses on the development and qualifying phase-appropriate assays in support of:

  • Design and developability
  • Formulation development
  • Process development
  • GMP manufacturing
  • Bioconjugation
  • Release and stability testing for GMP material

Your product development program will be accelerated by leveraging our expansive in-house analytical capabilities, technologies, and knowledge to deliver methods tailored to your molecule.

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Global Team of Experts

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.

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, and/or bioconjugation.

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Our Capabilities

Our capabilities include the following:

  • Wet Chemistry assays (Appearance, pH, osmolality, etc.)
  • Chromatography (HPLC, GC, UPLC)
  • Electrophoresis (CE-Reduced & Non-reduced, icIEF)
  • Spectroscopy (UV-Vis, SoloVPE)
  • Binding Assays (ELISA)
  • Water Content (Karl Fisher)
  • Endotoxin (LAL)
  • Spectrometry Characterization (NMR, LC-MS)

We provide transparent and regular communications to ensure we meet your program goals and timelines.

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