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

Our well-designed analytical programs satisfy regulatory requirements and work to assure the success of the clinical 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 laboratories are equipped with sophisticated analytical instrumentation, enabling scientists to employ a full range of methodologies and techniques to characterize your product and develop test methods that will validate your product’s integrity throughout its life cycle.

Services

• Pyrogen-free materials
• Strict quality control is performed using various analyzers
• RP-HPLC
• IEX-HPLC
• MALDI-TOF/MS
• Residual salts testing and removal
• Endotoxin testing