Thermo Fisher development solution offers timelines of 13 months to clinic

Thermo Fisher Scientific released the ‘enhanced’ version of its ‘Quick to Clinic’ solution, noting that it could help take companies from DNA to drug product in "as little as 13 months"​ from transfection.

It showcased the new solution this week at BIO Digital 2021.

The company released the original solution in 2018, with the idea being to take biopharma concepts through to Phase I clinical trials and then onto filing for Investigational New Drug (IND) review as quickly as possible.

Now Thermo Fisher has updated the solution, with a company spokesperson telling BioPharma-Reporter that it had completely redesigned the start-to-finish workflow to reduce overall timelines.

Further than this, the upgraded solution has titers of 3-5g/L, using Thermo Fisher’s Gibco Freedom ExpiCHO-S expression system, and has incorporated multi-attribute analysis (MAM) technology for improved product quality analysis.

The latter technology is an automated MAM workflow that is used to obtain orthogonal glycan and charge variant data, as well as having the ability to monitor oxidation, O-linked glycans, and the presence of low-level impurities.

When asked about further examples of automation within the system, the spokesperson outlined: “Quick to Clinic also uses several high throughput automation tools such as systems for single cell cloning and clone screening and a miniaturized purification platform to optimize loading conditions.”​

The move to facilitate the rapid development of antibodies is part of a broader push by Thermo Fisher to provide services that speed up the biologic development process, with the company previously announcing a collaboration with the University of California ​​to aid the development of cell therapies.

Navigating risk​

According to Thermo Fisher, the drug development solution is suitable for new and emerging biotech and biopharma companies, typically those that have moved through target identification, validation and the lead molecule selection process. More specifically, the solution is aimed at developing immunoglobulin G (IgG) antibodies.

In terms of how working with Thermo Fisher helps such companies to avoid risks in the development process, the spokesperson identified that the speed of development can introduce problems into clinical-stage manufacturing, with the process platform used for early-stage production sometimes not appropriately optimized.

“While that’s an acceptable approach, it’s important to ensure that the process platform itself is sufficiently robust and that it enables reasonably smooth optimization during scale-up beyond Phase I,”​ the spokesperson explained.

Further than this, they noted that the choice of expression system or chromatography resins have a long-term impact beyond Phase I, with the additional factors of licensing terms, milestone payments, and exit fees associated with expression systems requiring consideration for both the IND stage and potential commercialization. Thermo Fisher stated that its experience in development and manufacturing would help companies avoid suck risks.