cGMP Stability Studies

Determination of shelf life to support clinical use and degradation profile is key to aiding the development and commercialization of a protein therapeutic.

At Fujifilm Diosynth Biotechnologies, we offer intelligent and robust solutions for your drug's stability programs, fulfilling regulatory requirements and supporting the drug development. Our analytical experts ensure the stability studies are managed efficiently and high-quality analytical data is delivered rapidly.


	Our standard storage facilities include:
	+5°C storage +25°C/ 60% relative humidity +40°C/75% relative humidity	-70°C freezer -20°C freezer Additional cabinets available to meet custom needs
	We offer cGMP long-term and accelerated studies for intermediates, drug substance, drug product and placebo. Our in-house dedicated stability group evaluates your product's stability and also the process and product consistency. We have on-site back-up storage units and dedicated spare capacity with 24/7 monitoring and rapid response systems.

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