Aseptic Fill/Finish
for Clinical & Commercial Supply
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Whether you need vials for an early-phase study, a syringe program taken to launch volumes, or an approved vial product moved onto a new line, our teams take your batch from compounded bulk to inspected, filled units.
At a Glance
The formats, lines, and components behind our aseptic fill/finish, laid out for a quick fit check against your program.
Container Closure Formats
Vials from 2R to 30R, 1mL prefilled syringes, and cartridges
Filling Lines
Five fill lines (one vials, two prefilled syringes, one flex, and one cartridges) at the West Chester, Ohio, site, plus two vial fillers at Toronto qualified for clinical and commercial supply
Containment
Isolators for prefilled syringes and cartridges, restricted access barrier systems (RABS) for vials
Components
Ready-to-use syringe and cartridge components, and in-house vial washing and depyrogenation for vials
Formulation
Compounding and formulation beside the fill lines at both West Chester, Ohio, and Toronto sites, plus aseptic formulation for suspension at Toronto
Sites
West Chester, Ohio and Toronto, Ontario, with clinical and commercial supply at both
Everything in One Place
[Asset scope: what the sheet covers, in the reader's terms], in a single [format] you can forward to your team.
Define Your Own Path
You choose your route through fill/finish by container closure format and stage, from small to mid-volume vial filling at Toronto to the high-speed syringe and vial lines at West Chester. Both sites operate under the same quality systems with a dedicated program team, so you get the same standard on whichever line your batch runs on.
Fill early-phase vials with minimal loss
Toronto's vial fillers run peristaltic pumps through a disposable fill path, filling small volumes accurately and keeping line loss low when you have little material to spare.
Take syringes to launch volumes
We fill prefilled syringes at West Chester inside an isolator from ready-to-use components, so a product scaling toward launch moves onto lines that already run commercial supply.
Move approved vials to commercial filling
West Chester's commercial vial line washes and depyrogenates ready-to-sterilize vials before filling them under RABS, so your transferred product arrives on a line that prepares its own containers.
Reference the site's sterilization validation
We keep current sterilization process validation information in the Type V facility Drug Master File, and a Letter of Authorization for the US market lets your filing reference it directly.
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Why Choose Resilience as Your Aseptic Fill/Finish CDMO
01
High-speed filling in commercial production
600 units per minute on the isolator prefilled syringe lines at West Chester, and 350 on the RABS vial line, all in commercial production.
02
Filling approvals from the US FDA
Prefilled syringe and vial filling approved in 2024, and cartridge filling approved in 2022.
03
Commercial supply to global markets
40+ markets supplied from our network. West Chester has shipped commercial product since 2012, and today supplies North and South America, Europe, Asia, the Middle East, the Caribbean, and Australia.
04
Product release within weeks of filling
Under 45 days from formulation to inspected batch release. Our QC chemistry and microbiology team at West Chester tests filled product onsite and works 24/7 across four shifts.
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FAQs
Which container closure formats does Resilience fill?
Resilience fills vials, prefilled syringes, and cartridges.
How fast are Resilience's aseptic fill/finish lines?
Resilience's commercial prefilled syringe lines at West Chester, Ohio, fill at 600 units per minute inside an isolator, and its commercial vial line fills at 350 units per minute under RABS. Toronto's vial fillers use peristaltic pumps, which fill small volumes accurately with minimal line loss.
Does Resilience fill in isolators or RABS?
Both. Resilience fills prefilled syringes and cartridges inside isolators at West Chester, Ohio, and fills vials under restricted access barrier systems, or RABS, at West Chester and Toronto
What vial batch sizes does Resilience fill at Toronto?
Resilience's Toronto site fills vial batches of up to 1,500 units on its clinical filler and up to 22,000 units on its commercial filler. Both fillers run under RABS, and the site fills vials from 2R to 30R.
Is Resilience adding aseptic fill/finish capacity?
Yes. Resilience has two more isolator fill lines under construction at its West Chester, Ohio, site, adding prefilled syringe, cartridge, and vial capacity to the lines already in commercial production there.
Does Resilience fill from ready-to-use components?
Yes, on its prefilled syringe lines. Resilience fills syringes at West Chester from ready-to-use components inside an isolator. Its vial lines across the network work from ready-to-sterilize vials, washing and depyrogenating them before filling, so programs built around either component model have a line.
Does Resilience's aseptic fill/finish follow EU GMP Annex 1?
Yes. Resilience's sites across the network apply Annex 1 quality risk management principles and contamination control strategies across all programs. The quality team also tracks Annex 1 contamination control expectations through its regulatory intelligence work, alongside self-inspections and mock inspections.
Talk to Our Team
Tell us about your molecule, your stage, and the volumes you expect. We'll put you in touch with the people who would run the program.
