Large molecule CDMO services

Thermo Fisher Scientific provides integrated CDMO services for large molecule therapies, spanning development through clinical and commercial manufacturing. Capabilities include cell line development; upstream and downstream process development; analytical and formulation development; drug substance manufacturing; scale-up; process characterization and validation; process performance qualification (PPQ); sterile fill-finish; packaging; regulatory support; and commercial supply. Our network supports biologics, including monoclonal and bispecific antibodies and recombinant proteins, as well as viral vectors and mRNA therapies.

Yes. Thermo Fisher Scientific supports large molecule programs across the product lifecycle, from pre-IND/IMPD and IND/IMPD-enabling development through Phase I–III clinical manufacturing, scale-up, process performance qualification (PPQ), and commercial supply. Integrated development, manufacturing, regulatory, and sterile drug product capabilities help facilitate technology transfer, regulatory readiness, and manufacturing continuity as programs advance toward commercialization.

Thermo Fisher Scientific has extensive late-stage manufacturing experience across biologics and advanced therapies. Our large molecule network has completed more than 620 biologic and 580 viral vector commercial and PPQ batches, as well as more than 325 biologic and 295 viral vector clinical batches. We have also supported 240+ biologic programs and approximately 25 BLA submissions over the past five years, demonstrating experience in scale-up, PPQ, regulatory readiness, and commercial manufacturing.

Yes. Thermo Fisher Scientific provides sterile fill-finish services for large molecule therapies, extending support from drug substance manufacturing through finished sterile drug product. Capabilities support biologics, viral vectors, and mRNA therapies from development and first-in-human supply through commercial-scale manufacturing, with formulation development, aseptic filling, lyophilization, inspection, packaging, and regulatory support available across the product lifecycle.

Thermo Fisher Scientific supports a range of sterile drug product formats for large molecule therapies, including liquid-filled vials, lyophilized vials, prefilled syringes (PFS), and prefilled cartridges. Capabilities span development through commercial-scale manufacturing, with packaging and autoinjector pen assembly available where applicable. These flexible formats help accommodate product, dosing, and delivery requirements as programs progress toward commercialization.

Yes. Thermo Fisher Scientific offers integrated drug substance and drug product services that connect large molecule development and drug substance manufacturing with sterile fill-finish. Coordinated planning across formulation, technology transfer, scale-up, aseptic manufacturing, analytical support, and packaging can help reduce handoffs between providers, simplify transfer activities, and support continuity from clinical development through commercial supply.

Drug developers should consider a CDMO’s experience with their molecule or modality, breadth of development and analytical capabilities, drug substance and sterile drug product expertise, scalability, technology transfer capabilities, regulatory experience, quality systems, and commercial readiness. A partner with integrated services and a global manufacturing network can help reduce handoffs, manage risk, and maintain continuity as a program advances from early development through clinical manufacturing, process performance qualification (PPQ), and commercial supply.