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Thermo Fisher Scientific has introduced its new Quick to Clinic solution, which is designed to accelerate biologic drug development from discovery to the IND phase in a shortened period.
Thermo Fisher Scientific’s new and enhanced Quick to Clinic solution may help biopharma companies reach Phase I/first-in-human trials and file for investigational new drug (IND) review in as little as 13 months from transfection, the company announced in a June 14, 2021 press release. With this solution, emerging biopharma companies working on early development can now leverage a lab-to-clinic drug development solution designed to accelerate the journey from DNA to drug product.
Quick to Clinic leverages Gibco Freedom ExpiCHO, which is a royalty-free, high-yield expression system that can scale seamlessly from an R&D environment. The solution also includes critical activities, such as cell line development, process fit, analytical development, and qualification, resulting in a robust process platform for biopharma companies developing mammalian recombinant proteins. This capability allows companies to scale quickly from discovery phase, leveraging toxicology and good manufacturing practice (GMP) material. In addition, documentation provided by the Quick to Clinic program will allow companies to file for IND in an expedited manner and get to Phase I clinical trials quicker.
Furthermore, Quick to Clinic leverages Thermo Fisher's global network of facilities and scientific experts, combined with its track record and more than 30 years of development and manufacturing experience, to help biopharma companies target an accelerated pathway to IND without taking on significant risks that would disrupt their goals. Biopharma companies will also be able to create a strong foundation for future scale-up success.
"Emerging biopharma companies now make up a majority of the biologics development pipeline. Meeting critical milestones is paramount to the continued support of these programs, making speed to clinic more important than ever," said Paul Jorjorian, vice-president and general manager, biologics, at Thermo Fisher Scientific, in the company press release. "With our Quick to Clinic solution, we provide biopharma companies with the supply assurance and foundational platform they need to see their therapy through to the clinic that mitigates risk, accelerates timelines, and navigates the complex and changing regulatory environment. Ultimately, this will help to expedite the development of important medicines for patients."
Source: Thermo Fisher Scientific