Process & Analytical Development for Programs with GMP in Sight
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Whether you're developing a product from scratch, refining your purification strategy, or further developing your analytical methods for qualification and validation, our teams take your molecule from early lab work through to manufacturing scale.
At a Glance
The scales, methods, and laboratory capabilities behind our development work, so you can see how your program fits before we talk.
Development Scale
Bioreactors from under 1L to 500L for process development and scale-up
Molecules
Monoclonal antibodies, plasma-derived biologics, recombinant proteins, and other complex molecules
Purification
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 Development
Method development, qualification, and validation, plus design and execution of development and ICH-compliant stability programs
Stage Coverage
PPreclinical, Phase I and II clinical programs through Phase III and commercial
Laboratories
Toronto, Ontario, has 7,000 square feet of process development laboratories and 6,000 square feet of QC laboratories on a 136,000-square-foot cGMP site
Everything in One Place
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One Site. From Development Forward.
Your program enters where it needs to and advances with what comes next already in view. Process development, biologics drug substance manufacturing, and aseptic vial filling are all available at our Toronto site, supported by technical leadership and program management that stay with your program throughout its lifecycle.
Develop the process around your molecule
Process development and scale-up run in our multi-modal process and analytical development laboratories, so your process is worked out at development scale with GMP in mind before it reaches manufacturing.
Design the purification route
Chromatography, membrane separation, ultrafiltration and diafiltration, virus inactivation and removal, and conjugation, chemical or enzymatic, are developed on the same site that runs them at manufacturing scale.
Build the methods that confirm it
Analytical method development, qualification, and validation, with ICH-compliant stability programs designed and executed on-site by our QC chemistry and microbiology teams.
Move into GMP manufacturing
Your process and analytical package move into biologics drug substance manufacturing and aseptic vial filling at the same site, with the technical lead and program manager assigned to your program staying with it.
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Why Choose Resilience as Your Development and Analytical CDMO
01
Long development record at one site
15+ years of development and manufacturing experience at our Toronto site. More than 850 batches have been manufactured and released there, 550 of them commercial.
02
Dedicated laboratories for development work
7,000 square feet of process development laboratories, alongside 6,000 square feet of QC laboratories. The site runs 24/7 across multiple shifts.
03
Current inspection record across three regulators
100% regulatory inspection success rate since 2019. The US FDA, Health Canada, and PMDA have all successfully inspected our Toronto site.
04
Deep tenure on your program team
15+ years average team tenure at our Toronto site. The quality and regulatory teams there have an average of more than 20 years of experience.
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FAQs
What does Resilience's process and analytical development include?
Resilience's process and analytical development covers process development and scale-up of biologics, purification development, formulation development, and analytical method development, qualification, and validation. ICH-compliant stability programs are designed and executed alongside. All of it runs at our Toronto, Ontario, site.
Does Resilience develop analytical methods and run stability studies?
Yes. Resilience develops, qualifies, and validates analytical methods and designs and executes ICH-compliant stability programs in its own QC chemistry and microbiology laboratories in Toronto.
Does Resilience develop methods for both clinical and commercial programs?
Yes. Resilience qualifies and validates analytical methods for Phase I and II clinical programs and for Phase III and commercial programs at its Toronto, Ontario, site, and designs and executes ICH-compliant stability programs for both.
How does development work move into GMP manufacturing at Resilience?
It stays on-site. Resilience develops your process and analytical package at its Toronto, Ontario, site, where biologics drug substance manufacturing and aseptic vial filling also take place, and the technical lead and program manager assigned to your program remain with it.
Where does Resilience do process and analytical development?
Resilience runs process and analytical development at its Toronto, Ontario, site, in 7,000 square feet of process development laboratories, with 6,000 square feet of QC laboratories alongside. The site is a 136,000-square-foot cGMP facility that also runs biologics drug substance manufacturing and aseptic vial filling.
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.
