Large molecule development and manufacturing services
CDMO solutions to meet the unique needs of biologic drugs
Large molecule drugs, or biologics, are derived from living organisms and are inherently complex to develop and manufacture. In comparison to small molecule chemical API, biologic drugs most commonly end up in a parenteral drug product rather than in an oral dose. Biologic drugs including antibody therapies are on the rise due to their unique ability to treat and/or prevent rare diseases like various cancers, Chron’s disease, multiple sclerosis, and cystic fibrosis.
Thermo Fisher Scientific has industry-leading experience in the biologics space, having worked with 50+ large molecule drugs sourced from mammalian antibodies, including both traditional and nontraditional monoclonal antibodies, and we bring our deep scientific expertise to every project.
We apply our comprehensive CDMO solutions for large molecule drugs to help increase the batch yield and reduce processing time for your biologic. Additionally, our proven track record of scaling up biologics can help mitigate risk and reduce costly delays at every stage of development and manufacturing, with processes that ensure:
- Repeatability
- Reliability
- High quality
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
Large molecule CDMO solutions and capabilities
Biologics development and manufacturing
The biologics development process is complex and is often accompanied by important milestones that biotechnology and pharmaceutical companies must meet. We understand the ins and outs of biologics development, and we can provide the strategic guidance and flexible solutions you need to succeed. Our team of experts is driven by science and comes with a proven track record of scaling up biologics production. Specifically, our biologics development and manufacturing capabilities for mammalian-based antibodies include:
Process development and validation
Cell line development and simple cell line licensing
Clinical batch supply
Quick to Clinic platform to IND/IMPD in 13 months
Technology transfers to mitigate risks and delays
Quality control and analytical services
Biologics commercial manufacturing expertise
Aseptic manufacturing and fill finish
The sterile pharmaceuticals market is expected to expand by more than 50% over the next seven years, and sterile manufacturers need to create more capacity quickly to capture additional market share. Our flexible aseptic manufacturing and sterile filling solutions are designed to meet your large molecule’s unique needs and help overcome key challenges in early development, late-phase, and commercial manufacturing. Specifically, our aseptic manufacturing and fill finish capabilities can help:
- Overcome formulation challenges like solubility and stability
- Build a robust process development program
- Navigate a complex regulatory environment (IND, filing, etc.)
- Build success in early development to enable commercial successs
- Shorten timelines to get your drug to market quicker