- Home
- Companies
- National Resilience, Inc.
- Services
- Outcome-Driven Biologics Manufacturing ...
Outcome-Driven Biologics Manufacturing Services
As recombinant protein and monoclonal antibody treatments continue to provide promising pathways for both existing indications and new ones, Resilience has the clinical and commercial experience, expertise and capacity to be your preferred manufacturing partner. Regardless of which of our Biologics teams and facilities across North America take the lead on your project, our goals are the same: to streamline and accelerate your path to first-in-human studies by more efficiently integrating late discovery activities with early development and to apply our clinical and commercial manufacturing excellence to provide robust and reliable supply for your patients.
ACCELERATED PATH TO ll\ID
- End-to-end cell line development (CLD), formulation, process and analytical development (PAD), with early-stage clinical manufacturing for fed-batch or continuous production to provide flexibility and speed for first-in-human (FIH) programs
INNOVATIVE EXPRESSION & MANUFACTURING PLATFORMS
- Multiplexed CLD accelerates transition to development by enabling CLD on a parallel path
- Continuous Manufacturing (perfusion upstream and continuous downstream unit operations) improves product quality and cost of goods
- Cell Free Protein Synthesis provides greater flexibility, control and production speed for scaling difficult to manufacture biologics
- Perfusion experience and capacity with continuous purification capability
ROBUST CLINICAL& COMMERCIAL MANUFACTURING
- Extensive experience and expertise in vaccines, mAbs, enzymes, fusion proteins, and bispecifics
- Strong network of facilities, equipment, materials, digital solutions, and operational excellence to fit your program’s specific needs
- Early phase to commercial tech transfer
- Optimization of clinical programs for robust and reliable commercial supply of bulk drug substance and drug product
- 35+ years of commercial manufacturing experience in products distributed over 70 countries
- Expansion of 10 single-use process lines at 500L-2,000L scale
- Certified multi-product facilities
- Cell bank GMP production (MCB and WCB)
- Integrated formulation and fill finish
- Extensive network of drug product fill/finish capacity
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