Sterile Drug Product Manufacturing for Vials, Syringes and Cartridges
Whether you're preparing a first clinical fill, finalizing a device presentation for launch, or building the regulatory file for approval, our teams carry your molecule from formulation to labeled units ready to ship.
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At a Glance
The presentations we fill, the finishing that follows, and who signs the batch off before it leaves the site, so your team can size up the fit early on.
Container Closure Formats
Vials, prefilled syringes, and cartridges
Formulation
Solution, suspension, and other complex presentations, with single-use technology on most systems
Finishing
Manual and automated visual inspection, device assembly, packaging, labeling, and serialization
Modalities
Small molecules, biologics, and peptides
Release and Stability
In-house QC chemistry and microbiology covering release and stability
Sites
West Chester, Ohio, and Toronto, Ontario. Clinical and commercial supply at both
Find Resources Matched to Your Program
Answer a few questions about your molecule, your container closure format, and your timeline, and we'll come back with what is relevant to where your program is today.
Define Your Own Path
Your program sets its own route through sterile drug product manufacturing, and the standard holds whichever route it takes, because every stage runs on integrated quality systems with a dedicated program team. Formulation, aseptic filling, visual inspection, and release run together, and we maintain the facility's own Drug Master File, so the regulatory package leaves with the product.
Formulate and fill to the presentation
Your formulation, developed here or transferred in as an established process, then filled aseptically into vials, prefilled syringes, or cartridges, so the line is qualified around your presentation.
Inspect and release on-site
Automated visual inspection to clear the filled batch, followed by in-house chemistry and microbiology testing for release and stability, with disposition done on the site that filled it.
Finish into distribution-ready goods
Device assembly, labeling, packaging, and serialization, turning released units into finished goods coded and cartoned for the markets you supply.
Draw on the site's own regulatory file
A Type V facility Drug Master File and a Letter of Authorization for the US market, backed by Module 3 review, GMP dossiers, variations, and Health Authority responses, so your submission can cite the site directly.
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Why Choose Resilience as Your Sterile Drug Product CDMO
01
Proven execution at commercial scale
220M+ sterile drug product units released across the Resilience network. At West Chester, filling, device assembly, and packaging all run for commercial supply, and a single site can carry your product from compounding to finished goods.
02
One quality record across the network
100% regulatory inspection success rate since 2019. The US FDA has inspected the network sites regularly, most recently in a routine cGMP inspection in 2025, and the West Chester device assembly operation is certified to ISO 13485 for drug-device combination products.
03
Automated inspection in commercial production
600 units per minute on 2R vial inspection and 400 on 10R vials and prefilled syringes, with both Brevetti® and Körber® technologies operated in commercial production.
04
Direct access to your program team
One quality professional for every five in manufacturing, in a quality and regulatory group averaging more than 20 years of experience. That experience sits with your program from technology transfer and validation through commercial manufacturing and release, and fewer layers mean a packaging change or an inspection question reaches someone who already knows your product.
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FAQs
What does Resilience's sterile drug product manufacturing include?
Resilience's sterile drug product manufacturing includes formulation, aseptic fill/finish (vials, prefilled syringes, and cartridges), manual and automated visual inspection, in-house release and stability testing, device assembly, packaging, labeling, and serialization. All of it runs inside one North American operation.
What is Resilience’s timeline from formulation to market-ready units?
Resilience moves a program from formulation through aseptic fill/finish, inspection, device assembly, packaging, and serialization to labeled, market-ready units in under 60 days, including release.
Which modalities does Resilience support?
Resilience fills monoclonal antibodies, plasma-derived biologics, recombinant proteins, peptides, and small molecules. Container closure and process are matched to the requirements of the product rather than to a single manufacturing platform.
Does Resilience maintain a Drug Master File for its drug product site?
Yes. Resilience maintains a Type V facility Drug Master File and provides a Letter of Authorization for the US market, so your submission can reference the site directly. The file carries current sterilization process validation information, and its regulatory team reviews client Module 3 documents under the quality agreement.
Can Resilience fill biological drug substance supplied by the client?
Yes. Resilience fills client-supplied biological drug substance using its full range of drug product services. Biological drug substance manufactured at its Toronto site can also be transferred into aseptic fill/finish at West Chester, so both routes are available.
Does Resilience do analytical and microbiology testing in-house?
Yes. Resilience runs QC chemistry and microbiology at its sites within network, covering raw materials, in-process, filled product, and device release testing alongside method transfer, verification, and stability testing.
Where does Resilience manufacture sterile drug product?
Resilience manufactures sterile drug product in North America, at its West Chester, Ohio, site and its Toronto, Ontario, site, both of which run clinical and commercial supply. West Chester handles commercial filling, automated inspection, device assembly, and packaging, while Toronto handles formulation and aseptic fill/finish alongside biological drug substance manufacturing.
Talk to Our Team
Tell us about your molecule, your stage, and the volumes you expect. We'll put you with the people who would run the program.
