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Advancing innovation across biotech workflows
Bringing a new therapy to clinic as a biotech company means balancing ambitious development goals with limited resources—while keeping programs on track for critical milestones. Early research, CMC strategy, process development, and scale-up often need to move in parallel as supporting data is still taking shape for IND submission.
At Thermo Fisher Scientific, we can help you with your efforts to reduce risk and accelerate timelines with integrated development, manufacturing, and regulatory support—so you can move from molecule to clinic with confidence.
Turn your innovation into clinical progress
Bringing a biologic to the clinic requires more than science; it requires alignment across development, CMC, manufacturing, and regulatory strategy. Working with trusted suppliers can help you move forward with clarity and confidence toward key milestones for IND submission and first-in-human studies.
A clear path from discovery to IND
Thermo Fisher can support you from discovery to clinical entry, helping streamline your development journey through aligned, scalable solutions.
- Discovery
- Process development
- Analytical strategy
- GMP manufacturing
- Clinical entry
Start strong with a molecule that is built for success.
- Optimize cell lines, media, and feed strategies to increase productivity and stability
- Assess developability early, including scalability and manufacturability
- Generate data to support confident lead selection decisions
Build a process that scales with your ambition.
- Develop scalable upstream and downstream processes, including tailored purification strategies using appropriate tools
- Align CMC strategy with clinical and regulatory goals
- Enable efficient scale-up with appropriate systems and technical support
Build confidence in your molecule before it reaches the clinic.
- Develop analytical methods and product characterization strategies
- Perform impurity profiling and assessments to meet regulatory expectations
- Generate reliable, high-quality data through optimized workflows
Scale your process and prepare for clinical trials with confidence.
- Transition to GMP manufacturing for IND-enabling studies
- Leverage scalable single-use bioprocessing technologies
- Access cGMP chemicals, process liquids, and supply chain solutions to support continuity
Move confidently into the clinic with the right support in place.
- Prepare IND-ready documentation, including CMC sections
- Align with FDA expectations and regulatory strategy early
- Access technical support, from setup through verification and submission
Why partner with us?
End-to-end specialist support
We support the various stages of your bioprocessing journey with integrated technical knowledge.
Process design tailored to your needs
Our specialists work with you to develop data-driven, customized workflows that improve efficiency, scalability, and product quality.
Global network. Local support.
Collaborate with over 2,000 scientists and access Bioprocess Design Centers, supported by flexible services and hands-on technical knowledge tailored to your needs.
Scalable, flexible technologies
From single-use systems to optimized media and feeds, our solutions are designed to scale with your process and adapt to your needs.
Move faster with specialist support
Whether you are optimizing your molecule, building your CMC strategy, or preparing for clinical trials, Thermo Fisher can help you move forward with clarity, confidence, and speed.
Bioprocessing solutions
Our bioprocessing technologies and tools support flexible, end-to-end workflows that adapt as development evolves. From early-stage optimization to scale-up, our solutions help streamline decisions and accelerate progress across diverse applications.
Frequently asked questions
For IND submission, analytical methods do not need to be fully verified, but they must be qualified and reliable enough to support patient safety and product quality.
Many delays stem from late-stage CMC issues, analytical gaps, and challenges with process scalability.
Earlier than most teams expect—ideally during lead selection—to help avoid downstream delays.
CMC strategy involves numerous decisions across development. Among the most important are achieving the right balance between process understanding, scalability, analytical confidence, manufacturing strategy, and working with the right partner.
GMP manufacturing is required for producing clinical trial material, so the transition should occur once a reproducible process and control strategy are established—typically during IND-enabling activities.
Most early-stage biotech companies benefit from early collaboration with a CDMO to facilitate manufacturability, scalability, and regulatory readiness.
Additional bioprocessing resources
Bioprocessing resources
For research use or further manufacturing. Not for diagnostic use or direct administration into humans or animals.