New and emerging biopharma companies working on early development can now leverage a better lab to clinic drug development solution designed to accelerate the journey from DNA to drug product. The enhanced Quick to Clinic solution from Thermo Fisher Scientific 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 new solution will be showcased this week at BIO Digital 2021.
“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. “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.”
Quick to Clinic leverages Gibco Freedom ExpiCHO – a royalty-free, high-yield expression system, that can scale seamlessly from an R&D environment – and includes critical activities such as cell line development, process fit, analytical development and qualification, yielding a robust process platform for biopharma companies developing mammalian recombinant proteins. This allows companies to scale quickly from discovery phase, leveraging toxicology and GMP material and documentation provided by the Quick to Clinic program to file for IND in an expedited manner and get to Phase I clinical trials quicker.
Jorjorian continues, “Quick to Clinic leverages Thermo Fisher’s deep scientific and technical expertise, spanning decades of experience in end-to-end molecule development with more than 240 recombinant proteins and monoclonal antibody products. In addition, it features state-of-the-art technology including high throughput automation tools for cell line and process development, liquid chromatography-mass spectrometry-based multi-attribute methodology for critical quality attributes analysis, and design of experiment tools for high throughput screening.”
Quick to Clinic leverages Thermo Fisher’s global network of facilities and scientific experts, combined with its proven 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 while creating a strong foundation for future scale-up success.