Your Scale Up CDMO Partner for Large Scale Manufacturing
Access to large scale bioreactor capacity represents hope for patients in need.
As you scale up from small to large scale, clinical or commercial, your CDMO partner should provide you the technical and regulatory expertise to successfully navigate your journey to large scale cGMP manufacturing.
Let us be your complete outsourcing partner for scaling up your biologics. We are adept at providing fast ramp-up and seamless technology transfer to deliver life-impacting medicines for our commercial partners worldwide.
Global Partnership Right Where You Need It
Our cGMP facilities with locations in Hillerød, Denmark and Holly Springs, NC, USA provide adaptable and flexible capacity, and:
- Teams with vast experience and expertise, supported by robust integrated quality systems
- Unprecedented delivery with high-throughput, leading-edge technologies, and expansion opportunities to meet your capacity demands
- Sustainability targets in alignment with Fujifilm’s Sustainable Value Plan 2030
To offer you best-in-class service, our teams are able to build and ramp up capacity at unprecedented speed utilizing our modular approach for construction or expansions as needed. Our standardized processes, procedures and equipment ensure high quality cGxP executions. This approach allows ultimate flexibility providing an end-to-end experience where your biologics move seamlessly from drug substance to drug product to their final delivery format. These efficiencies support rapid technology transfers and deliver your therapeutics to patients’ hands with the highest quality and safety.
Offering over 16 years of commercial production expertise, our staff at the the Hillerød, Denmark facility are versed in clinical and commercial production of mammalian biopharmaceuticals. The site offers:
- N-1 perfusion capable, allowing for higher cell densities, shorter cell culture durations, and greater productivity.
- 6 x 20,000 L stainless-steel bioreactors with ongoing expansions to a total of 20 x 20,000 L by 2026.
- Drug product and finished goods: liquid filing capabilities, plus assembly, labeling and packaging of final drug product into its drug delivery formats
Located in a biomanufacturing hub, our Holly Springs, NC, USA site will be operational by 2025 with 8 x 20,000 L stainless steel bioreactors. The site will also offer:
- 8 x 20,000 L stainless steel bioreactors by 2028.
- Additional capacity for 16 x 20,000 L, making the site the largest end-to-end cell culture CDMO facility in North America (with a total capacity of 32 x 20,000 L)
- Drug product and finished goods: liquid filing capabilities, plus assembly, labeling and packaging of final drug product into its drug delivery formats.
Versatility of Modules:
Manage Your Pipeline How You See Fit
For your drug substance, your own ‘4-pack suite’ gives you the access you need for flexibility to use it as you would like. Combine your programs as you see fit and manage your pipeline efficiently.
Get the ‘keys’ to your 4-pack suite, offering you modules of:
- 4 x 20,000 L bioreactors
- Two upstream trains
- One harvest suite
- One purification suites
- Systems architecture
Master your data
Have visibility to real-time batch execution data. Stay informed and make data-driven decisions.
Gemba / Go see
Opportunities for commercial manufacturing clients to have a person-in-plant to observe critical operations.
Your Supply Chain Has Never Been Easier
Ensure reliability in your supply chain through working with one partner who can provide quality manufacturing for late stage clinical and commercial programs. We use equivalent systems, equipment, and processes across our large scale network to give you the assurance that you will get the same quality from either our Denmark or North Carolina facilities. In addition, through functional equivalency, we can partner to generate supply chain redundancy and to speed up regulatory approval from one site to the next.
Once your drug substance scale reaches the commercial level, we offer you an all-encompassing drug product and finished goods experience in order to be your true Partner for Life.
As your CDMO partner, you will have access to our drug product aseptic filling service that uses a robotic isolator with single-use product path to meet your program’s needs. We offer clinical and commercial batches up to 150,000 units to support large scale biologics using RTU nested components for your liquid drug product in vial, syringe, or cartridge format.
- Drug product formulation development support
- Accelerated and long-term stability studies
- Release of clinical and commercial products – including European qualified persons
- Assembly, labeling and packaging support under our finished goods services:
- Assembly into auto-injectors and PFS components
- Labeling of vials, PFS and auto-injectors
- Primary packaging in single or multi-unit pack format
- Secondary packaging
