Lyophilization and processing.
Open to all vendors.
Contract freeze-drying, fill-finish, and analytical services from a purpose-built facility. Built by operators who got tired of waiting in someone else's queue, and now run it for everyone else too.
Everything between your powder and a finished vial.
Take the whole chain or take one piece. Most clients start with a single pilot lot and scale from there.
Contract lyophilization
Freeze-drying to your spec or ours. Cycle design, primary and secondary drying, stoppering under controlled conditions.
Fill & finish
Vial filling, capping, and sealing. Standard vial formats supported; unusual formats quoted case by case.
Formulation & cycle development
Excipient selection, cake structure, residual moisture targets, and a documented cycle you can take anywhere.
Analytical testing
HPLC purity and potency through our own analytical lab, open to outside clients whether or not we run your lyo.
Packaging & labeling
Kitting, labeling, serialization-ready lot coding, and finished-goods packout to your artwork.
Cold chain & storage
Controlled storage between steps and validated shipping to your 3PL, distributor, or direct to the pharmacy.
Five steps. No surprises at the end of them.
You get the cycle, the data, and the COA. If you leave, you leave with all three.
Scope and quote
Send us the molecule, the target format, and the volume. You get a written quote with a per-unit price and a lead time, not a range.
Incoming material testing
Your raw powder is tested by an independent third-party lab on arrival, before it touches a machine. If it fails, you know before you have paid for a run.
Cycle development and pilot lot
A small lot proves the cycle. You approve cake appearance, reconstitution behavior, and residual moisture before we scale.
Production run
Full lot under the approved cycle, with in-process records kept against your batch number.
Release testing and COA
Finished vials go back out for independent testing. Purity, actual content in mg, endotoxin, and net content per vial. Nothing releases without the certificate.
Tested twice, by someone who does not work for us.
Most contract facilities test once, at the end, on purity alone. That catches the wrong failures. We test the raw material on arrival and the finished vials after lyophilization, both through independent labs.
Four numbers on every certificate.
- Incoming raw powder. Identity and purity before the lot is accepted.
- Finished vials. Purity, actual content in mg, endotoxin, LPS and TPS.
- Net content per vial. Purity alone does not catch underfill. We ask for the number that does.
- Published COA. Every lot, tied to a batch number, delivered with the shipment.
Irvine, California
Skypark / MacArthur corridor. Space built out, equipment in transit, personnel hired and in training.
The specifics.
Numbers get published as equipment is commissioned. Nothing here is a projection dressed as a fact.
Open to all vendors. That is the whole point.
We are not here to compete with our clients' brands. We run the process and hand back the product.
Compounding pharmacies
Overflow lyophilization capacity without buying a machine or waiting on a queue you do not control.
Research suppliers
Consistent vials with an independent COA behind every lot, which is increasingly what buyers demand.
Supplement and OTC brands
Powder stabilization, format conversion, and packout under your artwork.
Clinics and medical groups
Small, documented lots for in-house programs where the paperwork has to hold up.
Other labs
Analytical testing as a standalone service. You do not have to send us the lyo work to use the lab.
Startups
Pilot lots without a minimum that only makes sense at ten times your volume.
Tell us what you need run.
Molecule, format, volume, timeline. You get a real quote back, not a discovery call.
Under NDA on request. We sign yours or send ours.