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Product Quality & Analytical Services

The cornerstone of any product development and manufacturing effort is the analytical characterization and validation of all raw materials, in-process materials and finished product.

Our well-designed analytical programs satisfy regulatory requirements and work to assure the success of the development program. Our dedicated analytical scientists customize phase-appropriate analytical programs to the specific needs of your unique molecule delivering a comprehensive understanding and characterization of the molecule for each stage of development and commercialization.

Our on-site analytical Highly Potent/ADC laboratories are equipped with sophisticated equipment, enabling our dedicated analytical methods development team and QC release/stability testing teams to employ a full range of methodologies and techniques to characterize your product and develop test methods to validate your product’s integrity through its life cycle.

Analytical services:

  • Raw materials testing
  • Cleaning (LC/QQQ), TOC
  • HPLC/UHPLC/2D-LC
  • Characterization
    • IR/MALS
    • LC/MS/MS
    • Sub Visible particles
  • CE, icIEF
  • UV/VIS
  • SDS-PAGE, ELISA (LBA)
  • Environmental / bioburden testing
  • Compendial Testing (LAL, osmolality, moisture)