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Accelerate your biologics development with Thermo Fisher Scientific’s integrated platform
Discover how Thermo Fisher Scientific’s new integrated platform is designed to address the unique challenges facing today’s biologics drug developers, enabling projects to reach IND/IMPD and Phase I clinical trials in as few as 8 months*.
In today’s fast-paced, ultra-competitive biologics market, drug developers are racing to submit their projects for IND/IMPD consideration to initiate Phase I clinical trials. Thermo Fisher Scientific understands this need for speed, and we’ve developed an integrated platform that can help deliver drug substance (DS) and drug product (DP) manufacturing services—along with clinical packaging, labeling, and distribution—all in one platform, in as little as 8 months.*
Meet important drug development milestones with confidence
This integrated platform provides a fast track to success, combining Thermo Fisher Scientific’s extensive experience in biologics development with cutting-edge tools, advanced methodologies, and a proven CHO-K1 GS knockdown cell line—a commercially ready option capable of delivering antibody titers up to 8 g/L.* This dependable solution is tailored to scale up recombinant antibodies from development to Phase I trials, providing the following features:
- Flexibility: Our platform offers options tailored to your specific program needs
- Speed: Rapidly optimize your biologics production processes with our support
- Regulatory support: Confidently navigate complex regulatory landscapes
- Preclinical manufacturing: Meet quality standards and compliance requirements
- Analytical testing: Comprehensive testing services for your biologics products
- Performance analysis: Our multi-attribute method provides comprehensive data
Download our fact sheet to learn more about the details of this integrated platform for accelerated biologics development, and explore how our global network of facilities can help move your program forward, from beginning to end—including cell line development, preclinical-scale production, sterile fill-finish, and beyond.
*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 and start of clinical trials 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. 8-month timeline will incur additional risk and is based on US-based sites only. Timeline for clinical trials is dependent on clinical trials being conducted in Australia or New Zealand.
