15 June 2021 | News
Enhanced solution delivers balance of speed and quality to accelerate and expedite DNA to Investigational New Drug in as little as 13 months
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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.
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.
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.