The new version of Quick to Clinic utilizes Thermo Fisher's Gibco Freedom ExpiCHO royalty-free, high-yield expression system that can scale from a research and development environment, according to the firm. It is designed to enable biopharma companies to reach phase I trials and file for investigational new drug (IND) reviews with the U.S. Food and Drug Administration (FDA) in as little as 13 months from transfection.
Quick to Clinic also supports activities such as cell line development, process fit, analytical development, and qualification, Thermo Fisher said.
As a result, companies developing mammalian recombinant proteins can utilize the platform to ramp up quickly from the discovery phase, leveraging toxicology and good manufacturing practices material and documentation provided by Quick to Clinic to file for an IND in a more expedited manner, according to Thermo Fisher.
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