Benefit from reliable analytical services

Reliable, robust analytical methods are imperative for successful drug development and commercialization. Method development, qualification, and validation play a pivotal role in understanding the critical quality attributes of the molecule, which help to define the robust control strategy required to manufacture and commercialize biologic molecules. Thermo Fisher Scientific’s global presence for supporting development and commercialization is a key asset that provides flexibility to our clients. At Patheon, by Thermo Fisher Scientific, we engage our world-class analytical capabilities to understand and characterize your molecule in a phase-appropriate manner. Early-stage development focuses on speed and efficiency to provide the Quick-to-Clinic™ advantage. Late-stage development implements the thoroughness required for a regulatory approach and successfully commercialization of your molecule. Maintaining the balance between speed and quality is our goal, ensuring that we provide the best services for successful analytical development. Examples include:

  • Developing and optimizing analytical methods for biologics
  • Technology transfer, qualification and validation of analytical methods
  • Providing analytical tools to perform protein characterization
  • Generating release and stability data to support IND/BLA filing
  • Performing comparability and forced degradation study to support process development

Our broad range of analytical services and capabilities ensures that you always have access to the tools and know-how you need, to achieve successful process development and commercial manufacturing of biologics. Array of analytical methods used for development and commercial manufacturing of biologics  

The development and manufacturing teams (clinical and commercial) work hand-in-hand to achieve seamless knowledge transfer. Thermo Fisher Scientific has implemented standardized workflows and templates to ensure that your product can be manufactured at any of our sites with minimal changes to equipment and processes. Platform analytical methods and harmonized analytical policies help to maximize efficiencies across the global network.

Learn more about residual impurity analysis for continuous manufacturing in this article from BioPharm International

Contact us to learn how to get the high-quality analytical data you need to make critical decisions with confidence, and maximize the quality of your product and processes.

Download our Biologics Overview Fact Sheet