YOUR CELL THERAPY
Innovators in immunotherapy, stem cell therapy, and regenerative medicine will find like-minded champions at Resilience.
A POWERFUL ALLY IN
CELL THERAPY MANUFACTURING
Cell therapy is one of medicine’s great new frontiers. We’re pioneering how its most productive explorations can benefit your team by uniting and improving every component – processes, scale-up, raw material supplies, analytics, release testing and GMP strategy.
We’re on a mission to drive down COGS and to reduce vein-to-vein time while maximizing our understanding of biological insights to address regulatory concerns and manufacturing robustness. With digitally-native cell therapy manufacturing, platforms enabling time to IND in as little as 9 months and in-house release testing, we’re pushing the boundaries to get your therapy to patients, sooner
As we bring each new cell therapy technology online – from blood cell processing to genetic manipulation and baseline analytical testing – your team will be positioned to unleash the potential of that innovation.
- B cells (B lymphocytes)
- Chimeric antigen receptor T-cells (CAR-T)
- Hematopoietic stem cells (HSC)
- T-cell receptor (TCR)
- Tumor-infiltrating lymphocytes (TIL)
- Natural killer cells (NK)
- Induced pluripotent stem cells (iPSC)
Accelerated Path To IND
- End-to-end support for clinical and commercial GMP manufacturing, from viral vector design and manufacturing, to release of commercial cell therapies
- Full regulatory and quality support and a fast-track to first-in-human (FIH) for clinical products
Innovative Immune Cell Manufacturing Platform
- Accelerate timelines by plugging into an optimized modular autologous immune cell manufacturing platform to get to a GMP cell therapy product in as little as 9 months
- All core unit operations closed and adaptable to your product specific needs
- Gene editing
- Autologous and allogeneic cell therapies
- End-to-end digital workflows enabling transparency to customers
Integrated Process & Analytical Development
- Comprehensive analytical development and assay capabilities in house to support extensive product characterization
- Cutting-edge platforms for deep characterization of the starting material, process and cell product
Robust Clinical & Commercial Manufacturing
- Expertise, capability, and capacity to support program life cycle needs from early-phase clinical to commercial cell therapy manufacturing
- Process development, analytical development, and GMP manufacturing co-located in our 85,000 sq ft. facility
- Viral vector manufacturing platforms at your fingertips (LVV/AAV/RVV)
- Electronic batch records
Experienced CMC & Regulatory Support
- Seasoned regulatory team with an average of 20+ years of experience working alongside product development leaders to provide CMC and regulatory support from pre-clinical development to licensure
- Multi-tiered support to fit your stage of product development and needs
- On-site QC testing & and regulatory support to accelerate product development
- 50+ GMP batches released since 2023
A POWERFUL ALLY IN CELL THERAPY
You don’t have to fear the future if you define it. Let us help you de-risk your strategy and give your innovation its best destiny.
Let’s Start a Conversation
You’ve no doubt filled out a million forms before. But this is the first one to us – and we’re excited to hear from you. Let’s see if your biomanufacturing needs and our capabilities are a good match.