Thermo Fisher Scientific Clinical Solution Delivers Accelerated Development for Biologics
Thermo Fisher Scientific presented its new Quick to Clinic solution, designed to accelerate biologic drug development from discovery to IND phase in a shorter time frame.
Thermo Fisher Scientific’s New and Improved Quick to Clinic Solution Can Help Biopharmaceutical Companies Achieve Phase I / First Human Trials and Submit an Investigational New Drug Review (IND) in as little as 13 months from the transfection, the company said in a June 14 statement. , press release 2021. With this solution, emerging biopharmaceutical companies working in early development can now take advantage of a laboratory-to-clinic drug development solution designed to accelerate the transition from DNA to drug product.
Quick to Clinic is built on Gibco Freedom ExpiCHO, which is a royalty-free, high-performance expression system that can evolve seamlessly from an R&D environment. The solution also includes critical activities, such as cell line development, process adjustment, analytical development and qualification, resulting in a robust process platform for biopharmaceutical companies developing recombinant mammalian proteins. This capability enables companies to scale rapidly from the discovery phase, leveraging toxicology and good manufacturing practices (GMP). In addition, the documentation provided by the Quick to Clinic program will allow companies to apply for an IND on a faster basis and to access Phase I clinical trials more quickly.
Additionally, Quick to Clinic leverages Thermo Fisher’s global network of facilities and scientific experts, combined with its track record and over 30 years of development and manufacturing experience, to help biopharmaceutical companies achieve target an accelerated path to IND without taking significant risks that would disrupt their goals. Biopharmaceutical companies will also be able to create a solid foundation for future scale-up success.
âEmerging biopharmaceutical companies now represent the majority of the biologics development pipeline. Meeting critical milestones is paramount to the continued support of these programs, which makes speed of access to the clinic more important than ever, âsaid Paul Jorjorian, Vice President and General Manager, Biologics, at Thermo Fisher Scientific, in the company’s press release. “With our Quick to Clinic solution, we are providing biopharmaceutical companies with the assurance of supply and the basic platform they need to get their treatment to the clinic that mitigates risk, accelerates turnaround times. and navigate the complex and changing regulatory environment. Ultimately, this will help speed up the development of important drugs for patients.
Source: Thermo Fisher Scientific