Reliable Commercial Supply for Pharma
Pharmaceutical Programs
Commercially licensed operations designed to support your product through every stage of growth.
Your product is supported by commercially licensed operations where filling, inspection, device assembly, packaging, and release are part of one quality system, built to support reliable supply as demand evolves.
220M+
sterile drug product units released across our network
40+
markets supplied
<60
days from formulation to market-ready product release
100%
OTIF delivery of commercial supply since 2023
What Commercial Supply Runs On
Commercial supply demands consistency across batches, changing demand, regulatory expectations, and the full lifecycle of a product. Here's how we deliver it:
Quality for Commercial Supply.
Quality is embedded throughout our operations, from technology transfer and validation through manufacturing, testing, release, and continued commercial supply. Our experienced quality and regulatory teams provide the rigor and continuity expected for marketed products.
Connected Operations. Better Visibility.
Digital systems connect manufacturing and quality workflows from raw material management through testing and release, giving our teams visibility, control, and data integrity throughout the process. Cybersecurity practices protect those systems, the operations behind them, and your program data.
Aligned With Your Sustainability Goals.
Resilience tracks Scope 1, 2, and 3 emissions across its operations, participates annually in EcoVadis, and is progressing through the Science Based Targets initiative (SBTi) target-setting process.
By advancing our own carbon reduction strategy, we support our partners as they work toward their broader sustainability, responsible sourcing, and value-chain emissions goals.
One Relationship. More of Your Portfolio.
The needs of a commercial portfolio rarely stop at one product or one presentation. Multiple products, formats, and stages can run inside a single manufacturing relationship, which simplifies coordination while giving your team greater continuity as needs change.
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Start Where You Want. Stay as Long as You Need.
01
Tech Transfer
A stage-gated approach with defined checkpoints moves your established process into our network, supported by process characterization, validation, and regulatory expertise from transfer through commercial readiness.
02
Biologics Drug Substance
Clinical and commercial manufacturing of monoclonal antibodies, plasma-derived biologics, recombinant proteins, and other complex molecules, in single-use bioreactors with capacity up to 2,000L. Start with us in Toronto for drug substance manufacturing, or bring your existing drug substance directly into our sterile drug product network.
03
Sterile Drug Product
Formulation and aseptic filling into vials, prefilled syringes, and cartridges, with analytical and microbiological testing for release and stability on the same campus. Under 60 days from formulation to labeled, market-ready units.
04
Device Assembly, Packaging, and Logistics
Assembly onto the device platform your program has selected, then labeling, serialization, packaging, cold storage, and finished goods supply.
Everything Your Commercial Plan Needs
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Why Choose Resilience as Your Pharma CDMO
A commercial partnership at scale
$750M committed with Lilly in July 2026 to expand our Ohio manufacturing and add KwikPen® device manufacturing, bringing approximately 400 new jobs, with full operations expected in early 2027. We have manufactured Lilly medicines since 2023.
A regulatory record across the network
100% regulatory inspection success rate across our network since 2019, covering FDA cGMP and pre-approval inspections, Health Canada, PMDA, and EMA, plus EU Annex 1 assessments. Quality risk management principles and contamination control strategies follow Annex 1 across all programs at our network sites.
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A certified operation for combination products
ISO 13485 certification held at West Chester since January 2024, covering contract manufacture of drug-device combination products and autoinjectors. Automated visual inspection and six packaging bays sit on the same site as the fill lines.
Multiple fill lines in commercial production
600 units per minute for prefilled syringes and 350 for vials. Automated inspection on the same site runs at 600 vials and 400 syringes per minute.
The Latest From Resilience
View More InsightsResilience Further Advances North American Manufacturing Strategy Transformation
The Future of CDMOs: Navigating the Combinations Interview with Kothari and Jonathon Amaya-Hodges
On Demand Webinar: Outsourced Pharma Capabilities Update - Large Molecule
Resilience and Lilly Invest $750 Million to Increase U.S.-Manufactured Medicine Supply
FAQs
Does Resilience manufacture sterile drug product at commercial scale?
Yes. Resilience runs commercial aseptic fill/finish, automated visual inspection, device assembly, and packaging across its network.
Can Resilience take on a product that is already approved and in commercial supply?
Yes. Resilience runs a stage-gated tech transfer with defined checkpoints, including the process characterization and validation that support commercial supply, and transfers into its network sites run under 10 months. Both our West Chester and Toronto sites are commercially licensed.
Can Resilience support more than one product for the same company?
Yes. Resilience supports multiple products, presentations, and container formats inside a single manufacturing relationship, across drug substance, sterile fill/finish, device assembly, packaging, and finished goods. A program manager and technical lead are assigned per program and stay with it for its lifecycle at Resilience.
Is Resilience's device assembly operation certified to ISO 13485?
Yes. Resilience holds ISO 13485 certification at its West Chester, Ohio, site, covering contract manufacture of drug-device combination products and autoinjectors.
How does Resilience use digital systems in commercial manufacturing?
Resilience connects manufacturing and quality workflows through digital systems covering raw material management, manufacturing operations, testing, and release. Those systems give Resilience teams visibility, control, and data integrity across a run and let them pull accurate, up-to-date program information when they ask for it.
How does Resilience support regulatory work on a product already on the market?
Resilience handles marketing authorization variations and responds to agency RFIs, and supports market expansion as your product moves into new territories. Its regulatory teams work alongside yours rather than in place of them, and a Type V facility Drug Master File with a Letter of Authorization covers the US market.
Does Resilience report on its sustainability performance?
Yes. Resilience committed in December 2025 to set science-based emissions reduction targets through the SBTi process, maintains a scorecard with EcoVadis through annual assessments, and is preparing to report environmental actions publicly through CDP. The facilities page carries the detail your ESG and procurement teams will want.
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.
