Capability
Lyophilization CDMOs
Compare CDMOs with lyophilization capabilities for biologics, peptides, and injectable products. Filter by dryer capacity, cycle development expertise, and scale.
180 companies listed
About Lyophilization Manufacturing
Lyophilization (freeze-drying) removes water from a drug product to extend shelf life, improve stability, and enable room-temperature storage. It is essential for many biologics, peptides, and injectable products that degrade in liquid form. The process involves freezing, primary drying (sublimation), and secondary drying (desorption).
Cycle development is the critical expertise. A well-designed lyophilization cycle minimizes processing time while maintaining product quality. Poor cycle design leads to cake collapse, meltback, or incomplete drying. Look for CDMOs that use thermal analysis (DSC, FDM) to determine critical formulation temperatures and optimize drying parameters. Modern CDMOs may also use process analytical technology (PAT) for real-time monitoring.
Scale-up is not straightforward. A cycle that works in a lab-scale dryer (1-2 shelves) often fails at production scale (20+ shelves) due to differences in heat transfer, condenser capacity, and chamber geometry. CDMOs with multiple dryer sizes (pilot, clinical, commercial) can demonstrate scalability within their own facility, reducing tech transfer risk.
Companies (180)
PeptiStar Inc.
Japan
PeptiStar is a Japan-based CDMO specializing in the development and cGMP manufacture of peptide and oligonucleotide APIs. From its 10,500 m² R&D and manufacturing site in Settsu, Osaka, the company supports programs from milligram-scale research material through clinical and commercial production. PeptiStar works with complex peptide structures, including long-chain, cyclic, branched and constrained peptides, non-natural amino acids and peptide conjugates. Its route-flexible manufacturing platform includes conventional and microwave-assisted SPPS, STag-PS and SYNCSOL liquid-phase technologies. Integrated downstream capabilities include preparative and continuous chromatography, membrane concentration and lyophilization, with 300 L filter reactors, chromatography columns up to 450 mm and lyophilizers up to 500 L. Purification and subsequent processing are conducted in Class 100,000 controlled areas. PeptiStar also develops and manufactures oligonucleotide APIs and peptide–oligonucleotide conjugates. The company was recognised by Exelixis as its 2025 CDMO of the Year.
Peptide APIOligonucleotide APIAPI Manufacturing
Vetter Pharma
Germany
Vetter Pharma is a leading global Contract Development and Manufacturing Organization specializing in aseptic fill-and-finish services for injectable drug products. Headquartered in Ravensburg, Germany, Vetter operates as an independent, family-owned business with over 75 years of experience.
Biologics Drug ProductFill/Finish (Vials)Fill/Finish (Syringes)
Frequently Asked Questions
When is lyophilization needed?+
Lyophilization is typically needed when a drug product is unstable in liquid form and would degrade during its required shelf life. Common candidates include monoclonal antibodies, vaccines, peptides, oligonucleotides, and certain small molecules. It is also used when cold-chain distribution is impractical (enabling room-temperature shipping) or when the drug must be reconstituted at point of use for dosing flexibility.
What should you look for in a lyophilization CDMO?+
Evaluate cycle development expertise (do they have formulation scientists experienced with your product type?), dryer fleet (number and size of lyophilizers, shelf temperature range, condenser capacity), analytical capabilities (moisture analysis, reconstitution testing, cake characterization), and regulatory track record with lyophilized products. Also check if they offer integrated fill-finish and lyophilization, which simplifies logistics.
Need help finding the right CDMO?
Our AI Matchmaker analyzes your project requirements and matches you with qualified manufacturing partners. Free for buyers.
