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Integrated platforms to accelerate biologics development
Progress to IND/IMPD submission and Phase I clinical trials in parallel
Reduce development complexity and accelerate critical program milestones through integrated mammalian cell line development, process development, GMP drug substance manufacturing, GMP sterile fill-finish, and clinical supply services.
Whether you're advancing a new biologic candidate or transferring an existing program into GMP manufacturing, Thermo Fisher Scientific offers flexible service pathways that help lay the foundation for future clinical and commercial manufacturing.
Key benefits
8 months*
DNA to IND/IMPD readiness
2 months*
Toxicology study material availability
CHO-K1 cell line and transposase technology
Achieves up to 8 g/L titer levels*
Clinical to commercial scalability
Biologics development and manufacturing strategies designed to support future scale-up
The science behind our accelerated services:
Our accelerated biologics development services leverage advanced technologies, software, and real-time feedback across our global network of facilities to efficiently advance biologics programs.
Here’s how we do it:
- Cell line development: AI/ML-enabled vector and gene construction, high-yield CHO-K1 cell lines, as well as afucosylated and transposase technology.
- Advanced software and profiling: Multi-attribute method (MAM), leveraging liquid chromatography-mass spectrometry (LC-MS), to obtain glycan profiling, purity, and charge variant analysis.
- Analytical testing: Comprehensive testing services designed to help ensure the safety, purity, and potency of your biologics.
Accelerated timelines 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 one of our flexible, accelerated pathways for integrated biologics manufacturing?
Thermo Fisher’s flexible and accelerated pathways are 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 the CHO-K1 GS knockdown cell line, a commercial-ready cell line capable of delivering antibody titers up to 8 g/L.*
High titers
Achieve unprecedented titer levels of up to 8 g/L* across Fc-containing molecules, including Fc-fusions and bispecifics.
Faster timelines
Advance from DNA to Phase I clinical trials in as little as 8 months* with an integrated CDMO and CRO partner.
Regulatory support
Benefit from our deep understanding of regulatory requirements to help ensure compliance and mitigate risks.
Scalable
Collaborate with one partner all the way. Our services are designed to support future clinical and commercial manufacturing.
Thermo Fisher Scientific helps emerging and established biopharma companies advance their biologics programs through flexible development pathways and integrated drug substance, sterile fill-finish, and clinical supply manufacturing solutions designed to support critical milestones from development through Phase I clinical trials.
Ready to discuss your program? Meet with an expert today.
Global network of experts and facilities from development to drug product readiness
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Figure 1. Integrated platform capabilities. 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. The timeline from DNA to drug product and the start of clinical trials may vary depending on molecule type or other factors and is an estimate to be finalized after third-party cell line development dates are available and confirmed. The 8-month timeline will incur additional risk and is based on US-based sites only. The timeline for clinical trials is dependent on clinical trials being conducted in Australia or New Zealand.
Frequently asked questions (FAQs):
Our accelerated services are designed to help clients go from DNA to IND/IMPD readiness in as little as 8 months*, with toxicology study material available in as little as 2 months* for qualifying programs. Actual timelines depend on molecule characteristics, development strategy, and project scope.
Our accelerated biologics development services support a range of molecule types, including:
- Monoclonal antibodies (IgG1 and IgG4)
- Bispecific antibodies
- Fc-fusion proteins
- Other Fc-containing biologics
Our development pathways can also support technology transfer programs for existing molecules.
By connecting cell line development, process development, analytical testing, GMP manufacturing, sterile fill-finish, and clinical supply through a coordinated global network, we reduce technology transfer complexity, improve communication between teams, and help accelerate critical development milestones.
Yes. Clients can choose manufacturing pathways based on their program needs, including US-based or global manufacturing options. Our integrated network allows programs to transition efficiently between development, clinical manufacturing, sterile fill-finish, and clinical supply while maintaining consistent project oversight.
Our development strategies are designed with scalability in mind. By establishing robust cell lines, scalable manufacturing processes, and integrated development workflows early, we help create a strong foundation for future clinical and commercial manufacturing.
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