Analytical Development Services

The highly experienced analytical development team covers a wide range of analytical methods from small molecule analysis through to cell killing assays and ELISA development.

We support the analytical development, validation, and quality control release testing needed to get ADC or bioconjugate to clinic or market, all at one location. We also offer method development and testing to characterize ADC or bioconjugate in all vital quality attributes.

Analytical Development and Validation

  • Method development for HPLC (HIC, SEC, PLRP), icIEF, CE-SDS, SDS-PAGE, ELISA, Cell-Based Assays, and cleaning methods
  • Qualification/Validation or Transfer of Methods
  • Commercialization activities support

Drug Substance and drug product release and stability testing

  • State-of-the-art onsite quality control laboratory
  • Over 15 years’ experience of routine screening of ADCs, including cell based assays and ELISA
  • Toxicology, Bulk Drug Substance and Finished Drug Product release testing
  • Stability testing to ICH guidelines