Thermo Fisher Scientific’s Quick to Clinic™ platform is a comprehensive solution designed to help expedite biologics development. This innovative service integrates advanced technologies and expert guidance to streamline the path from discovery to clinic and help ensure your biologics can reach patients faster.
The Quick to Clinic platform is a specialized solution that combines Thermo Fisher’s extensive experience in biologics development with cutting-edge tools and methodologies. This dependable solution is tailored to scale up recombinant antibodies from discovery to first-in-human (FIH) trials, and offers a seamless, end-to-end solution that provides you:
Early non-GLP toxicology material Released drug substance Released drug product Stability data for IND Templated quality-reviewed reports Clinical trial packaging and labeling |
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Your cell line RCB, media/feed strategy*, and cell stability data. Our platform process, formulation and analytics development. |
Evaluation of our platform process Platform formulation Analytical methods Toxicology batch cGMP batch at any scale Validation and characterization study Stability testing |
Early non-GLP toxicology material Released drug substance (DS) Released drug product (DP) Stability data for IND Templated quality-reviewed reports Clinical trial packaging and labeling |
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Your cell line RCB, media/feed strategy*, and cell stability data. Our platform processes and analytics with commercially available RMs. |
Evaluation of our platform process Formulation development Platform analytical method Custom analytical method development Toxicology batch cGMP batch at any scale Validation and characterization study Stability testing |
Thermo Fisher’s Quick to Clinic platform is designed to address the unique challenges of biologics development. A critical aspect of any early development work is the cell line that underpins the platform process. This solution leverages transposase-based technology in CHO-K1 GS knockdown cell line, a commercial-ready cell line capable of delivering antibody titers up to 8 g/L.*
Helps to reduce development timelines and accelerate your biologic’s journey to clinical trials with innovative technology, giving you a competitive edge.
Commercial-ready CHO-K1 GS knockdown cell line capable of delivering antibody titers up to 8 g/L.*
Leverage our global network, team of seasoned professionals, industry-leading technologies, and state-of-the-art facilities to help overcome development challenges.
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Figure 1. Capabilities of the Quick to Clinic platform. Cell line development through clinical scale production process development, as well as analytical and formulation development, are completed at our state-of-the-art facility in St. Louis, Missouri. The process is then transferred to the Groningen, Netherlands facility for clinical scale production up to 500–2,000 L, and lastly moves to the Monza, Italy site for sterile fill-finish.
* Terms and Conditions: Titer levels provided are estimates based on third party results and may vary depending on molecule type or other factors. Timeline from DNA to drug product for all Quick to Clinic platform options may vary depending on molecule type or other factors and are estimates to be finalized after third party cell line development dates are available and confirmed.