Viral Gene Therapy Process Development
To successfully manufacture gene therapy products, your process needs to be cGMP-ready by design
Whether you are looking to start with multi-candidate screening or at a later stage, there are a variety of entry points at FUJIFILM Diosynth Biotechnologies, where a range of efficient and proven workflows are available for all stages of your journey.
Where We Can Help
Reveal your most productive candidate while understanding its critical quality attributes with our candidate screening and feasibility studies, which also provide material for generation of clinical data.
Candidate Screening
In the codon and promoter optimization world, there could be four to fifteen candidates with different promoters, codon optimizations, and gene of interest strategies regarding sizing and serotype design in a tissue that has multiple AAV serotypes. Candidate screening requires a minimal amount of platform bioprocessing, rapidly screening multiple different candidates simultaneously to identify the highest producing construct with an optimal critical quality attribute profile.
Feasibility Studies
Ensure process performance and scalability through feasibility studies. With a similar core process to candidate screening, feasibility studies include scale-up to generate material for your preclinical studies, biodistribution analysis, dose range finding prior to toxicology design, and more expansive product quality and residual analytics.
Remove uncertainties using our AAV platform approach that overcomes challenges in viral vector manufacture by offering access to a commercial-ready cell line, plasmids, and leading edge technologies.
In more complex scenarios when titer or quality need to be improved, our tailored process development provides the flexibility to meet the needs of your program, regardless of your scale or phase requirements.
