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Large molecule CDMO services
Flexible development and manufacturing solutions designed to support programs across all stages
Thermo Fisher provides contract manufacturing services for pre-IND/IMPD and IND/IMPD-enabling programs, along with Phase I–III clinical and commercial manufacturing for monoclonal and bispecific antibodies, recombinant proteins, viral vectors, and mRNA therapies.
We have a dedicated regulatory team with expertise across all phases of the molecule lifecycle.
With over 620 biologic and 580 viral vector commercial and PPQ batches completed and 325 biologic and 295 viral vector clinical batches completed, Thermo Fisher is uniquely suited to partner with drug developers seeking late-stage manufacturing.
240+ Biologic programs
Experience with 240+ biologic programs enables us to provide scientific and technical expertise
25 BLA submissions
We have demonstrated scientific and regulatory expertise, with ~25 BLA submissions completed over the past five years.
1,100+ molecules developed
We have worked on over 1100 molecules over the past five years
Key considerations in large molecule manufacturing
At Thermo Fisher Scientific, we focus on understanding the unique needs of your advanced biologic so that we can innovate tailored solutions to meet them. Leveraging our extensive experience as a CDMO partner, combined with access to products and tools that enable innovation, we provide you with the complete capability and adaptability needed to chart your own path with confidence.
Drug development and manufacturing services for large molecules
We apply our comprehensive CDMO services for large molecule drugs to help increase the batch yield and reduce processing time for your advanced biologic.
Move your biologic forward with the expertise and flexibility to reduce risk while maintaining product quality throughout development and manufacturing.
Keep the momentum of your mRNA program moving forward with flexible capabilities spanning development, manufacturing, and sterile fill-finish.
Navigate the complexities of gene therapy development with viral vector expertise that helps reduce risk and supports confident decision-making.
Deliver every dose with confidence through flexible sterile fill-finish capabilities designed to protect product quality from clinical through commercial.
Discover how Thermo Fisher supports large molecule biologics programs across development, scale-up, and commercial manufacturing.
Frequently asked questions about large molecule CDMO services
Thermo Fisher provides integrated large molecule CDMO services spanning process development, analytical testing, clinical manufacturing, scale-up, PPQ, and commercial manufacturing for biologics, including monoclonal antibodies, bispecific antibodies, recombinant proteins, viral vectors, and mRNA therapies. Our global network supports programs from pre-IND/IMPD through commercialization with flexible manufacturing technologies and regulatory support.
Yes. Thermo Fisher supports biologics programs across the full development lifecycle, from early development and IND/IMPD-enabling activities through Phase I–III clinical manufacturing and commercial supply. Our integrated CDMO capabilities help streamline tech transfer, scale-up, regulatory readiness, and global manufacturing continuity.
Thermo Fisher has extensive experience supporting late-stage biologics and advanced therapies manufacturing, including commercial-scale biologics, viral vectors, and complex large molecule therapies. Our network includes specialized biologics and advanced therapy facilities designed to support clinical and commercial production with scalable technologies and cGMP expertise.
Drug developers should evaluate an advanced biologics CDMO’s technical expertise, regulatory support, scalability, manufacturing flexibility, and commercial readiness. An ideal partner should offer integrated development and manufacturing capabilities, experience with complex biologics modalities, global quality systems, and the ability to support programs from early development through commercial launch.
Related Resources
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.
Brochure
Advanced therapy services
This “Advanced therapies” brochure outlines our end-to-end CDMO development and manufacturing services and solutions for advanced therapies, including viral vectors, cell therapies, and mRNA.
White paper
First-in-Human: Reach milestones sooner with a technology-driven approach to early-stage biologic development
This white paper explores our Path to IND program, which integrates next-generation technologies to accelerate biologics from discovery to clinic, including FiH trials.
Webinar
Addressing industry challenges in mRNA product commercialization
The rapid development and approval of mRNA-based vaccines during the COVID-19 pandemic has spurred a renewed interest in mRNA technology, with scientists exploring new application areas such as oncology, HIV, rare diseases, and even personalized medicine. While the speed of production and flexibility of mRNA are appealing, several industry challenges must still be addressed to realize the full potential and further expand its use. Learn more.