FUJIFILM Diosynth Biotechnologies has aimed to address Phase Appropriate GMPs to better support our customers as they move through the clinical development path. As a CDMO, we have found that we are in a unique position to approach Phase Appropriate Development strategies given the diversity of our customers. We do this in collaborative partnership with our customers. Our main goal is to reduce our customer’s risks.
Know What to do When
The right work at the right time can maximize productivity and efficiency while minimizing regulatory risks. How to move faster to product realization?
Be working together we strive to avoid the two main pitfalls which are doing too much too early or not doing enough as the product meets milestones and moves to the later clinical phases.
Doing Too Much Too Early
- Over-characterization of process parameters
- Artificially locking processes into sub-optimal schemes or poorly selected specifications
Doing Too Little Too Late
- Unclear or missing elements when control strategy is tested at scale
- Required restart of PC, PV or post PAI commitments
At FUJIFILM We Have Developed a Phase Appropriate Guidance System that:
- Ensures our customers don’t overlook activities
- Reduces compliance risk
- Applies our history and experience efficiently and effectively
In order to properly utilize the Phase guidance systems, a tool for guiding projects through development phases was developed at FUJIFILM Diosynth Biotechnologies. This tool includes 105 project deliverables in 13 general categories, including staff and training, equipment, documentation, data requirement, materials, quality control and analytical and quality management and more.
Our goal is to support our customers in bringing life-changing therapies to patient. By combining our Phase Appropriate Approach and the broad spectrum of services offered at FUJIFILM, we strive to become the biologic and vaccine CDMO Partner of Choice.