Linker PayloadsBioconjugates and Antibody Drug ConjugatesAnalytical Method DevelopmentFormulation DevelopmentProcess Development

Analytical Method
Development

Reliable methods to characterize your product

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

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.

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:

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

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 cell line, process, and formulation development, and/or bioconjugation.

Our capabilities utilized to support bioconjugation include the following:

Compendial​

    • Appearance (USP<790>/EP2.9.20), (USP<631>/EP2.2.2), (USP<855>/EP2.2.1)​
    • Osmolality (USP<785>/EP2.2.85)​
    • pH (USP<791>/EP2.2.3)

Safety

  • Residual Ligand ELISA (Kit Based)​
  • Endotoxin (LAL), (USP85 / EP2.6.14)​
  • Sterility
  • Bioburden

Small Molecule Characterization

  • 1D and 2D NMR​
  • Mass Spectrometry
  • FTIR
  • RP, NP, HIC and Chiral HPLC
  • GC Residual Solvents
  • Karl Fisher
  • DSC
  • DLS​

Antibody-Drug Conjugate Characterization​

    • HPLCESIMS

Structural characterization and purity

  • Determination of drug loading (DAR)
  • Analysis of conjugation site
  • Analysis of ADC homogeneity
  • Chromatographic and spectroscopic purity
  • Quantification of residual unconjugated drug
  • Aggregation profile