Biologics Drug Substance Manufacturing for Complex Molecules
Whether you're heading into the clinic, moving an established process, working through upstream or downstream development, or starting a process from scratch, our teams carry your program from early development to commercial supply.
At a Glance
Explore our molecules, manufacturing scales, and quality system to evaluate fit before our first conversation.
Modalities
Large molecule recombinant and complex proteins, including monoclonal antibodies, fusion proteins, enzymes, bispecifics, plasma and blood cell proteins, and non-cytotoxic conjugated proteins
Upstream
Cell Line Development, Cell Culture and Process Development, and bioreactor scales from under 1L to 2,000L for pre-clinical and cGMP manufacturing
Downstream
Various affinity and mixed-mode chromatography, membrane separation, ultrafiltration and diafiltration, virus inactivation and removal for mAbs and non-standard proteins, and non-cytotoxic conjugation, chemical or enzymatic
Analytical & Quality Control
On-site QC chemistry and microbiology, plus development, characterization, qualification, and validation of GMP and commercial methods for in-process, release, and ICH-compliant stability testing
Quality System
One integrated, digitally enabled quality system across our North American sites, inspected by the FDA, Health Canada, and EMA, covering phase-appropriate programs from IND through commercial supply
One Place for Everything
Explore our modalities, manufacturing scales, and development capabilities in one resource built for your team.
Multiple Entry Points.
One Standard of Execution.
Wherever your program begins with us, the same technical rigor and program leadership stay with it, providing continuity as your molecule advances from one phase to the next.
Start with your molecule
Process and analytical development, process characterization, and scale-up in single-use bioreactors from 3L to 500L, with a phase-appropriate testing strategy and process optimization that brings your cost of goods down as volumes grow.
Transfer an established process
A structured tech transfer with defined checkpoints brings your process into single-use manufacturing from 50L to 2,000L, with the process and method characterization, qualification, and validation your program needs at each phase.
Bring material for downstream only
Purification and non-cytotoxic conjugation for plasma, transgenic, and externally produced material, in flexible suites that will accept a downstream-only program without a schedule penalty.
Carry it forward into drug product
Formulation and aseptic fill/finish are available within the Resilience network, which keeps coordination and quality oversight with one team.
Why Choose Resilience as Your Drug Substance CDMO
Built on Experience. Proven in Practice.
01
Deep expertise in complex molecules
20+ years of expertise
Our teams bring technical depth to biologics that require more than a standard platform approach, with experience across complex proteins, recombinant proteins, fusion proteins, plasma-derived products, enzymes, bispecifics, and other challenging modalities.
02
Direct access to the technical team
220+ team members at our Toronto site.
You work closely with the scientists, engineers, and manufacturing teams responsible for your programs. Fewer layers mean faster communication, clearer decisions, and stronger continuity of process knowledge that stays with your molecule.
03
Proven Quality Systems
Your program runs under the same quality system from first clinical batch to commercial supply, with no secondary system for your team to qualify. You get one integrated quality system and an organization with the technical depth, regulatory experience, and operational discipline to support complex products and reliable commercial supply.
04
Fit-for-purpose design for your program
50L to 2,000L in single-use manufacturing trains. A molecule that needs its own process is the work our teams want on the schedule. Scale, process, and capacity are planned around what your program requires, and the full range runs at one site, so growth stays inside a facility you've already qualified.
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FAQs
At what scale does Resilience manufacture drug substance?
Resilience manufactures biological drug substance in single-use bioreactors from 3L to 500L for development and 50L to 2,000L for cGMP manufacturing at its Toronto, Ontario, site. That range supports clinical through commercial supply.
Which modalities does Resilience support?
Resilience supports monoclonal antibodies, recombinant and complex proteins from cell and transgenic sources, fusion proteins, enzymes, bispecifics, plasma-derived products, and non-cytotoxic conjugated proteins.
Can Resilience run a downstream-only program?
Yes. Resilience takes purification and non-cytotoxic conjugation programs using plasma, transgenic, or externally produced material, and schedules them the same way as a program that starts upstream.
Do I have to use Resilience for drug product too?
No. Your material can move into formulation and aseptic fill/finish within the Resilience network, or transfer to the partner you prefer. Programs can arrive with drug product already placed elsewhere, and that doesn't change how Resilience runs drug substance.
How does Resilience approach tech transfer and scale-up?
Resilience uses a stage gate approach from early-phase process development through commercial tech transfer, with process characterization and validation supporting late-stage and commercial manufacturing. A program manager and technical lead carry your program through each gate.
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.
