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.
- Raw materials testing
- Cleaning (LC/QQQ), TOC
- Sub Visible particles
- CE, icIEF
- SDS-PAGE, ELISA (LBA)
- Environmental / bioburden testing
- Compendial Testing (LAL, osmolality, moisture)