Biologics & Sterile Drug Product Manufacturing for Biotech
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Biotech
Bridge the gap between scale and speed with dedicated program leadership, transparent operations, and a trusted partner that treats your program as a priority.
From development through clinical manufacturing, we keep commercial manufacturing in mind. With one integrated phase-appropriate quality system and dedicated program management through all your stage gates for success.
At our Toronto site
270+
biologics, blood, plasma, and related product batches manufactured
99%
commercial batch success rate
Up to
2,000L
single-use bioreactor capacity
100%
schedule adherence over the last 12 months
What We Establish Before Your First Batch
Four fundamentals are established from the start: capacity, program leadership, quality, and milestone planning. These remain consistent as your program advances. Every program receives the same commitment to technical rigor, continuity, and execution.
Capacity matched to your program
Your program is matched to its own dedicated capacity rather than being allocated against a larger client’s forecast. This gives your program greater visibility and continuity throughout development, with capacity planned around your needs, so growth doesn’t cost you your place in the schedule.
Consistent and accessible Program Teams
A program manager and technical lead are assigned to your program and stay with it for its life cycle, carrying it through each stage-gate checkpoint, and you work directly with the scientists, engineers, and quality experts doing the work.
Quality that fits your phase
Development is built with quality in mind, and phase-appropriate clinical runs under the integrated quality system that supports our commercial programs, so the standard doesn't change as your program does.
Plans aligned to your milestones
Timelines move, data changes the development plan, and forecasts get revised. We align capacity and resources to the milestones you set and stay flexible to keep the plan current as the program progresses.
Early or Late Phase: We Start With Your Needs
01
Development
Process, analytical, and formulation development with process characterization, analytical strength, and production in single-use bioreactors from under 1L up to 500L, or direct to purification.
02
Tech Transfer
A stage-gated transfer with defined checkpoints brings expanding or established processes into our sites, with the process characterization and validation to support late-stage and commercial supply, and regulatory support running alongside it. Tech transfer at our network sites takes under 10 months.
03
Biologics Drug Substance
Clinical and commercial manufacturing of monoclonal antibodies, recombinant proteins, plasma-derived products, and other complex molecules, in single-use bioreactors with capacity up to 2,000L. Run this stage with us at Toronto, or supply your own material and start at the next one.
04
Sterile Drug Product
Aseptic filling into vials, prefilled syringes, and cartridges, then inspection, device assembly, packaging, and cold-chain logistics.
Everything Your First Program Needs
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Why Choose Resilience as Your Biotech CDMO
A timeline from formulation to release
<60 days from formulation to labeled, market-ready units.
One quality 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.
Broad expertise across the development workflow
20+ years of expertise on the teams, spanning process and analytical development, scale-up, process characterization, technology transfer, and validation.
Tenured teams at the biologics site
15+ years average team tenure at our Toronto site, where process and analytical development sit alongside drug substance and sterile drug product manufacturing. Our West Chester and Toronto sites are both commercially licensed.
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
Will Resilience prioritize my program if it's smaller than your largest clients?
Yes. Resilience matches each program to its own capacity rather than allocating it against a larger client's forecast, so your program keeps its slot as it scales. Your program manager and technical lead stay with it through every stage gate.
Does Resilience work with preclinical and early-phase biotech programs?
Yes. Resilience supports programs from preclinical and early phase through commercial tech transfer, with phase-appropriate process, analytical, and formulation development. Development runs in single-use bioreactors from 3L to 500L, and installed cGMP capacity runs from 50L to 2,000L.
Can Resilience carry a biotech program from early phase to commercial supply?
Yes. Resilience runs clinical and commercial programs under one integrated quality system, and its Cincinnati and Toronto sites are commercially licensed. Drug substance runs at Toronto or is supplied by you, and sterile fill/finish runs at both sites, so a program can scale without changing quality systems.
Who at Resilience works on my program day to day?
Resilience assigns a program manager and a technical lead at your first stage gate, and both stay with the program through commercial supply. You also work directly with the scientists, engineers, and quality experts running your molecule, and centralized data systems let those teams pull accurate program updates when you ask.
Can Resilience take over a program transferring from another CDMO?
Yes. Resilience runs a stage-gated tech transfer with defined checkpoints, including the process characterization and validation needed to support late-stage and commercial supply. A program manager and technical lead carry the transfer through each checkpoint.
What happens at Resilience if my program's timeline or forecast changes?
Resilience aligns capacity and resources to the milestones you set and keeps the plan current as the program progresses. Your program manager and technical lead carry the change through, and you work directly with the teams it affects.
Does Resilience support regulatory filings?
Yes. Resilience maintains a Type V facility Drug Master File and provides a Letter of Authorization for the US market. Its regulatory teams review your Module 3 documents and support the GMP dossiers your submission needs.
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.
