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Biologics CDMO services for drug developers seeking
early-phase to late-phase manufacturing
Capabilities including mammalian cell line development through commercialization services available
With more than 30 years of experience supporting biotech and pharmaceutical companies, we provide integrated biologics CDMO services from early development through clinical and commercial cGMP manufacturing.
Our capabilities span mammalian cell line development, process development, and drug substance manufacturing, with scalable capacity ranging from 50 L to 5,000 L. We support monoclonal antibodies, recombinant proteins, and complex biologics with solutions aligned to regulatory and manufacturing requirements.
Key biologics development and manufacturing highlights
12 commercial molecules
Successfully manufactured 12 commercial molecules from '20 -’25.
105 customers and 19 countries
From ’20 – ’25 we have served over 100 clients across 19 countries.
987 biologics batches
Successfully manufactured over 980 biologic batches ranging from pre-clinical to commercial across our 4 global sites from ’20 – ’25.
>32% of projects were complex molecules
Successfully produced traditional mAbs, bispecific, fc-fusion, and enzymatic molecules.
Explore our integrated biologics CDMO services
Our biologics CDMO services support mammalian manufacturing from early development through commercial-scale cGMP production.
High-performing, stable mammalian cell lines optimized for expression, scalability, and regulatory readiness to support efficient clinical and commercial manufacturing.
Phase-appropriate analytical methods and formulation strategies to support stability, comparability, and regulatory submissions across development milestones.
Mammalian cell culture optimization, scale-up strategy, and bioreactor alignment to improve yield, consistency, and manufacturability from development through commercial supply.
Purification strategies designed for monoclonal antibodies and complex biologics, focused on impurity clearance, yield optimization, and scalable cGMP transfer.
Risk-based process characterization and validation studies aligned to global regulatory expectations for commercial readiness.
Scalable mammalian biologics manufacturing services supporting clinical supply through commercial cGMP production across our global network.
Integrated development programs combining cell line, process, analytics, and cGMP manufacturing to accelerate clinical entry.
Why choose Thermo Fisher Scientific as your biologics CDMO?
Selecting a biologics CDMO requires proven scale, technical depth, and regulatory alignment. We are well suited to provide:
- Proven commercial biologics delivery
- Clinical to commercial scale-up
- Programs requiring flexible scale, ranging from 50 to 5,000 L
- Drug developers that require U.S. or internationally based manufacturing
- Integrated drug substance and drug product services
Frequently asked questions on biologics CDMO services
Yes, approximately 32% of projects successfully completed have been for bispecific, fc-fusion, and enzymatic molecules.
We leverage the CHO-K1 cell line for mAb antibody cell line production, as well as AI/ML for vector construction and optimization. Our internal studies have produced up to 11 g/L using this cell line in conjunction with our optimized process intensification protocol.
Yes. We have available space in our facilities to integrate equipment or processes to tailor-make your molecule.
Yes, we have two manufacturing facilities in the U.S. for drug substance production, which include our St. Louis, Missouri and Plainville, Massachusetts sites.
Yes, through our Path to IND platform, we provide drug developers with a completed drug product, including clinical pack, label, and cold chain transportation in as little as 9-months.*
A biologics CDMO provides integrated development and manufacturing services for biologic drug substances. These typically include mammalian cell line development, upstream and downstream process development, analytical method development, process characterization, and cGMP manufacturing for clinical and commercial supply. CDMOs also support a range of biologics, including monoclonal antibodies, bispecific antibodies, Fc-fusion proteins, and other complex biologics.
Global biologics manufacturing network
Our network supports mammalian cell culture–based biologics manufacturing across development and commercial scales.
Thermo Fisher Scientific's biologics facility in St. Louis, MO is a center of excellence in single-use bioreactor technology that specializes in mammalian cell development, process development, analytics, and end-to-end cGMP manufacturing services.
Explore our facility in St. Louis, MO
Thermo Fisher Scientific’s site in Brisbane, Australia is a state-of-the-art facility, specializing in clinical and commercial manufacturing services, including clinical cGMP manufacturing.
Explore our facility in Brisbane, Australia
Thermo Fisher Scientific’s site in Groningen, Netherlands specializes in preclinical and commercial cGMP manufacturing and scale-up of mammalian cell culture, recombinant proteins, and monoclonal antibodies.
Explore our site in Groningen, Netherlands
Thermo Fisher Scientific’s facility in Lengnau, Switzerland specializes in highly flexible bioproduction technologies, including single-use bioreactors up to 5,000 L and stainless steel bioreactors up to 12,500 L, providing a pathway from development to large-scale production as your manufacturing needs evolve.
Explore our site in Lengnau, Switzerland
Scientific leadership in biologics development and manufacturing
Our scientific and technical leaders provide deep expertise across mammalian biologics development and commercial manufacturing.
Elena Gontarz, PhD, St. Louis, Missouri, USA
Holding her PhD in biochemistry with over 10 years of experience in developing biologics for pharma companies, Dr. Gontarz is our resident expert in global analytical and process development, as well as formulation sciences. Currently, Dr. Gontarz is the Head of the Scientific and Technical Affairs team, leading CMC support and biologics programs from Phase I to commercial manufacturing. Meet with Dr. Gontarz to learn more about our analytical method lifecycle development, cell line development, process development, tech transfer, and late phase commercialization.
Palak Patel, St. Louis, Missouri, USA
With over 5 years of experience in early phase biologic development and delivering innovative solutions for pharma companies, Palak is one of our Scientific and Technical Affairs subject matter experts in cell line and cell culture development for biologics. Meet with Palak to uncover how our early phase biologics solutions can help you get your biologic to patients faster.
Otto P.J. Jurrius, Groningen, Netherlands
Holding his master’s degree in biotechnology with over two decades of biopharmaceutical industry experience, Otto is the General Manager at Thermo Fisher Scientific’s biologics manufacturing site in Groningen, Netherlands. Otto leads biologics project management, manufacturing, engineering, and general management across biologics development, as well as clinical and commercial manufacturing. Meet with Otto to learn more about our innovative clinical and commercial manufacturing capabilities.
Erica Byerley, Lengnau, Switzerland
With over 8 years of experience and degrees in both chemical engineering and biological sciences, Erica is our guru in single-use technology, technology transfer, process design, and operational readiness for biologics development through clinical manufacturing. Erica currently leads our global tech transfer engineering team at our brand-new facility in Lengnau, Switzerland. Meet with Erica to learn about our innovative single-use bioreactors or engineering designs that can accelerate your biologics development journey.
Kym Baker, PhD, Brisbane, Australia
Holding her PhD in immuno-vaccine development with over 30 years of experience in developing and manufacturing biologics for pharma companies, Kym has worked on over 400 biologics with 10 through to product commercialization. Currently, Kym leads our award-winning, globally regulatory-approved biologics manufacturing facility in Brisbane, Australia, serving client programs from Phase I to commercial manufacturing. Meet with Kym to learn more about how we can support your products' lifecycle from tech transfer to clinical and late-phase commercialization and manufacturing, or how R&D tax credit and the Clinical Trial Notification (CTN) Scheme in Australia can help accelerate your early phase product to market.
Biologics resources and insights
Explore additional insights and technical resources supporting mammalian biologics development, manufacturing, and regulatory readiness.
Webinar
Accelerating biologics development with strategies for success
This webinar explores how drug developers can deliver innovative biologics quickly, all while navigating regulatory requirements, clinical trials, production scale-up, and quality control.
Brochure
Large molecule development and manufacturing: Comprehensive offering enabling speed and flexibility
Remove complexity and bring your large molecule to market faster, with less costs and reduced risks utilizing our integrated and customizable offerings.
Infographic
A practical guide to writing robust chemistry, manufacturing, and controls dossier modules to support first-in-human trials
Do you need to get your first-in-human (FIH) paperwork in order? This informative checklist can help you draft phase-appropriate chemistry, manufacturing, and controls (CMC) modules for the common technical document (CTD).
White paper
What you need to know about process characterization and validation for biologic processes
A major factor in the growth of the biopharmaceutical industry over the last 20 years has been continuous innovation with monoclonal antibodies (mAbs), which now make up more than 50% of the overall biotherapeutic market.