Cell and Gene Therapy Services
FUJIFILM Diosynth Biotechnologies is a global CDMO with expertise in process development and manufacture of cell and gene therapy, and recombinant vector vaccines.
Let us be your CDMO partner for life – from pre-clinical development through to commercialization.
A CDMO partner for life
Our technical teams have a deep understanding of viral vectors and virus replication platforms, including AAVs, Adenovirus, Lentivirus, and oncolytic viruses.
We can provide development, analytical, and manufacturing solutions for your gene therapy product needs, and have further expanded our advanced therapy capabilities with the acquisition of a dedicated cell therapy manufacturing facility.
Process Development
We develop robust and scalable manufacturing processes by incorporating critical design parameters necessary for cGMP compliance and success.
Analytical Development
Our analytical teams specialize in the development, qualification, and validation of analytical methods to test and verify critical quality attributes of your product.
cGMP Production
As a leading CDMO with world-class cGMP compliant facilities, we provide effective and reliable production of cell and gene therapy and recombinant vaccines.
Our unique experience and capabilities
Recombinant technologies
- Expertise and experience in recombinant DNA technologies including transfection, transduction, and cloning
Virus technology
- Experience working with multiple viruses and viral vectors
- Generating RVB, MVB,WVB
- Virus titer or genome copy number and total particles determined by orthogonal methods
- Plaque purification
- Virus engineering: purification, inactivation, adaptation to cell lines
- Process residuals and impurity testing
High-quality Production Cell Lines
- Adherent cells – iCellis Nano, HYPERStack-36, CellSTACK
- Suspension cells – 10-2000L SUB
- Cell culture adaptation to serum free media.
Dedicated state-of-the-art cGMP facilities
- College Station, Texas, USA: process development and cGMP production of bulk drug substance and drug product up to 2,000L scale to support Phase I-III clinical and commercial requirements.
- Darlington, United Kingdom: process development and cGMP production of bulk drug substance up to 200L scale to support First In Human clinical requirements.
- Thousand Oaks, California, USA: clinical and commercial cell therapy manufacturing
- Watertown, Massachusetts, USA: process development and cGMP production of bulk drug substance up to 200L scale to support First In Human clinical requirements.