Lyophilisation (Freeze-Drying) Contract Manufacturing
Freeze-dried injectables in vials, made under your brand by sterile manufacturing sites in India with validated lyophilisation lines.
Freeze-drying protects products that are unstable in solution
Lyophilisation, or freeze-drying, removes water from a frozen product under vacuum, leaving a dry cake in the vial that is dissolved just before use. It is used for products that break down in solution, such as proton pump inhibitor injections, many oncology drugs, peptides, vaccines and other biologics.
Every product needs its own cycle of freezing, primary drying and secondary drying, developed in the laboratory and then proven at commercial scale. The cycle decides the cake's appearance, its residual moisture and how quickly it dissolves. Freeze-dryer time is also a common bottleneck, because cycles can take days and each dryer runs one load at a time.
We shortlist sterile sites that already freeze-dry products like yours and have validated cycles, freeze-dryer capacity and the inspections your market needs.
Tell us this to get a quote
- Molecule(s) and strength per vial
- Existing formula and cycle, or development needed
- Vial size and fill volume
- Diluent supplied with the product, or not
- Target market(s)
- Annual volume and first-order quantity
- Special handling: cytotoxic, hormone or beta-lactam
What to check in a freeze-drying manufacturer
Cycle development and scale-up
Who owns the cycle, how it was transferred from laboratory to commercial scale, and the validation batches behind it.
Moisture and cake quality
Residual moisture limits, cake appearance (collapse or shrinkage) and reconstitution time, at release and at the end of shelf life.
Freeze-dryer capacity
How many freeze-dryers the site has, their size, and how your batches will be scheduled alongside other customers.
Aseptic loading
Partially stoppered vials are moved into the freeze-dryer under aseptic conditions. Ask how loading and unloading are protected and covered by media fills.
Stoppering and container integrity
Vials are usually stoppered inside the freeze-dryer under vacuum or nitrogen. Ask for container closure integrity data for the vial and stopper used.
Stability and storage
Stability data for your climatic zone, in-use stability after reconstitution, and storage needs, which can include refrigeration.
Products often supplied freeze-dried
| Product type | Examples | Watch for |
|---|---|---|
| Proton pump inhibitor injections | Pantoprazole, esomeprazole | Alkaline solution, reconstitution time |
| Oncology products | Bortezomib, azacitidine, gemcitabine | Containment for cytotoxic products |
| Antibiotics and antifungals | Vancomycin, caspofungin, micafungin | Refrigerated storage for some products |
| Peptides and hormones | Bivalirudin, glucagon emergency kits | Low fill weights, moisture sensitivity |
| Biologics and vaccines | Some monoclonal antibodies and vaccines | Potency, cold chain, specialised sites |
Not every molecule needs freeze-drying. Some injectables are filled as sterile powder or as a ready-made solution instead, which is usually cheaper. We check which route fits your product and registration.
How it works with PharmaTradz
You send the product, form, market and volume.
Two or three plants that already make that type of product, with their approvals and country of manufacture. Names under a confidential disclosure agreement when the requirement is firm.
Samples of an existing product, or cycle development and stability batches for a new one.
Your brand, artwork and pack, and the dossier your market needs.
Production and release with a batch-wise Certificate of Analysis, sterility, endotoxin and moisture results. Cold-chain shipping where needed.
Scheduled batches with the same site, materials and documents.
Problems we see most often
Cycle fails at commercial scale
A cycle that works in the laboratory gives collapsed cakes or high moisture in a large dryer. Ask for scale-up and validation data, not only development results.
Freeze-dryer slots run out
Busy sites cannot fit extra batches at short notice, which delays launches and tenders. Agree annual capacity in advance.
Cakes rejected on appearance
Shrunken, cracked or collapsed cakes lead to complaints even when the drug is fine. Agree visual standards and defect limits in the specification.
Have a freeze-dried product in mind?
Send the molecule, strength, vial size, market and annual volume. We will tell you which sites fit and what data they hold.
Send your requirement Talk to our teamOther contract manufacturing
For refrigerated products see our cold-chain logistics service. Building your own brand across several products? See white label and third-party manufacturing, or the CDMO and contract manufacturing guide hub.
