Analytical Solutions for Biologics
Providing comprehensive and flexible analytical solutions to accelerate the development and approval of biologics
- State-of-the-art analytical methods to thoroughly assess and characterise critical quality attributes
- Science-driven analytical data and characterisation packages for demonstration of biosimilarity and establishing totality of evidence
- Phase-appropriate lifecycle approach to analytics for method development, qualification and validation
- Release and stability testing to support clients’ successful product launch in regulated markets including FDA, EMA and PMDA
- Global cGMP quality systems to support clinical and commercial biologics
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