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Path to IND for biologics:
Conquer key challenges in biologics development
Developing a biologic is inherently challenging. Whether it’s selecting the right CDMO and CRO partner, troubleshooting performance or process delays, or lobbying for sufficient funding. It can often feel like a never-ending journey.
But what if that’s just an outdated thought?
Thermo Fisher Scientific’s Path to IND for biologics was designed to conquer these key challenges head on—fundamentally changing the game for drug developers in the biopharma space.
What is Path to IND for biologics?
Path to IND for biologics is a one-of-a-kind biologics development platform that delivers titer levels of up to 8 g/L* of mAb, bispecific, or fc-fusion molecule. Utilizing Thermo Fisher Scientific’s state-of-the-art equipment, cutting-edge software, and full access to the depth and breadth of our resources—including raw materials and CRO services—this platform is not meant to just develop your biologic. It gets you to simultaneous IND/IMPD submission and initiation of Phase I clinical trials, funding and all, with a ready-to-go drug product in as few as 9-months.*
- Engineered for success: Leverages AI/ML-driven vector and gene construction, high-yield CHO-K1 cell lines, and transposase technology.
- Proven performance: Multi-attribute method (MAM), leveraging liquid chromatography-mass spectrometry (LC-MS), to obtain glycan profiling, purity, and charge variant data.
- Faster timelines: Advance from DNA to Phase I clinical trials in as little as 9 months* with an integrated CDMO and CRO partner.
- Higher titers: Achieve unprecedented titer levels of up to 8 g/L* across complex molecules, including Fc-fusions and bispecifics.
- Regulatory support: Benefit from our deep understanding of regulatory requirements to help ensure compliance and mitigate risks.
- Preclinical manufacturing: Assured high-quality and regulatory compliance during cell line development, production, and toxicology testing.
- Analytical testing: Comprehensive testing services to help ensure the safety, purity, and potency of your biologics.
Path to IND for biologics timeline and options by molecule type
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 |
Why choose the Path to IND for biologics?
Thermo Fisher’s Path to IND for biologics 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.*
Speed to market
Helps to reduce development timelines and accelerate your biologic’s journey to clinical trials with innovative technology, giving you a competitive edge.
Robust cell line
Commercial-ready CHO-K1 GS knockdown cell line capable of delivering antibody titers up to 8 g/L.*
Expertise and support
Leverage our global network, team of seasoned professionals, industry-leading technologies, and state-of-the-art facilities to help overcome development challenges.
Global network of experts and facilities from development to drug product readiness
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Figure 1. Capabilities of the Path to IND for biologics. 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 and start of clinical trials for all path to IND for biologics 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. 9-month timeline will incur additional risk.
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