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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.

Key Services

  • HPLC, UPLC, LC/MCS (QTOF & QQQ)
  • /MALS, QELS
  • CE, cIEF
  • UV-vis
  • SDS-PAGE
  • ELISA / LBA
  • Environmental / bioburden testing
  • Compendial Testing (LAL, osmolality, moisture)