CGMP Production
cGMP Production
Efficient Cell Culture cGMP manufacturing
FUJIFILM Diosynth Biotechnologies is a leading contract development and manufacturing organization (CDMO) providing full cGMP manufacturing of biologics, based on mammalian cell cultures and Insect Cell Cultures (ICC). For example recombinant proteins and monoclonal antibodies (mAbs).
We bring over 30 years of experience in process development, scale-up and cGMP production based on mammalian cell cultures, and 20 years of hands-on insect cell process experience to your program. We are a licensed manufacturer of a commercially approved insect-cell expressed product.
Let us be your complete outsourcing partner in the GMP manufacturing of pharmaceutical products.
A global manufacturing service – with flexibility, capacity and convenience
Our modern cGMP facilities provide a global service based on expertise, vast experience and state-of-the art equipment.
With a total of over 50 bioreactors ranging from 3 to 200 liters – we offer both flexibility, capacity and convenience.
We offer both single use (200L – 2,000L) and stainless steel (20,000L) manufacturing platforms . Our services include process development and optimization of fed batch and continuous processes for mammalian as well as insect cell-based production.
CGMP PRODUCTION BASED ON MAMMALIAN CELL CULTURES
FUJIFILM has extensive expertise and capabilities in the development and optimization of cell culture-based processes, as well as the ability to scale up for manufacturing. Our solutions support cGMP production of clinical as well as commercial products. We have vast experience from different suspension-based cultures, as well as adherent-based cultures for gene therapy.
The new Apollo X™ offers previously unseen speed, with about 10 weeks from transfection to RCB without compromising quality or yield (10 g/L).
This is achieved through a new – CHO DG44 – host cell line with superior biomanufacturing potential developed through directed evolution and a proprietary medium developed inhouse to remove several classic bottlenecks in cell line development.
CGMP PRODUCTION BASED ON INSECT CELL CULTURES (ICC)
FUJIFILM are a leading CDMO in insect cell-based production of biologics, and a licensed manufacturer of a commercially approved baculovirus expressed product. We bring over 20 years of hands-on insect cell experience to your program.
We have a deep understanding of the challenges and the expertise to make your insect cell program successful, not only in development but all the way to scale-up and full cGMP production. Our services include large scale insect cell / baculovirus expression of vaccine products and VLPs, executing validation campaigns and supporting BLA and commercial production.
LARGE SCALE CELL CULTURE CGMP PRODUCTION
FUJIFILM Diosynth Biotechnologies Hillerød, Denmark is a large-scale biologics cGMP manufacturing site located near Copenhagen. The new site consists of a campus hosting a large-scale production facility equipped with 6 x 20,000L bioreactors for the manufacture of cell culture derived biologics for clinical and commercial use.
CONTINUOUS MANUFACTURING
- Initial $10M USD for Proof of Concept Facility.
- 3 years of in-house innovation by Fujifilm group companies .
- An advanced upstream perfusion process utilizes a proprietary process control system with automatic feedback control for cell density and nutrient addition to maintain steady state conditions.
- Adapted Apollo X™ cell line for perfusion processing.
- Facility will include a 500L single use perfusion bioreactor and 7 patented downstream processing units that is expected to yield >15kg of antibody from a single 4 week batch at 500L scale.
