Assay Development, Qualification & Validation

Fujifilm Diosynth Biotechnologies' vast experience in biologics analytical development offers a strong platform for efficient and rapid method development, qualification and validation. Our robust systems ensure efficient development, with seamless and express transfer into GMP laboratories.


	Developed analytics to support >150 proteins Experience with wide range of analytical methods Highly experienced analytical experts Latest technology and instruments	Experience with broad range of analytical methods R&D and GMP laboratories and systems Qualification of "fit-for-purpose" methods to support early phase cGMP clininal release
	Our formal procedures ensure that studies are ICH compliant ensuring analytical methods demonstrate robustness and competency. Our analytical team has experience in various validation strategies to perform assay validation providing assurance on the method performance.

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