Phase III

Supporting your Clinical Phase 3/ Process Validation

The FDA estimates that 70% of programs will make it into Phase 2. Out of that 70%  only 30% will be moving to Phase 3. At this step in the clinical phase, a strong partnership with your CDMO is critical. With larger patient populations and longer clinical study designs, managing your supply chain will be very important as your Phase 3.

Will my CDMO be able to meet my Phase 3 Supply needs? Do they have the experience and infrastructure to support my process characterization? Is their approach to process characterization aligned with our goals? Do they have experience with process validation? Can they support my analytical method validation?

These are some of the questions that, as a partner, we bring our network and extensive experience to supporting our customers as they enter Phase 3 and plan to move towards process validation to support their Biologics License Application (BLA). By operating as a network, we offer the resources and infrastructure needed to successfully meet your timelines.

The Services we offer to support Late Phase Trials include:

  • FMEA- Risk Assessment
  • Process Characterization Study Design and Execution
  • Analytical Method Validation
  • Process Validation
  • Late Phase cGMP Manufacture
  • BLA Support for CMC Activities
  • Multi Lot Stability Studies

Risk Assessments at FUJIFILM diosynth: Designed for Success

Our philosophy on risk assessments is based on ICH Guidelines. It is Thorough, structured, and standardized and we do it as a joint partnership with our customers.  We have an inbuilt lists of variables based on our previous experiences in process characterization and manufacturing. We have developed our own tools to help facilitate this process with automated visual plots (i.e., heat maps, sorted score plots). We put emphasis on impact of each individual parameter on Critical Quality Attributes (CQAs).

Process Characterization

Our process characterization programs are designed with the depth (e.g. small, med, large) needed to meet our customer’s process requirements while also balancing timeline and resource needs vs. risks and benefits.

Process Validation

Our philosophy is to align early on process control strategy. We collaborate with our customers on pre-characterization FMEA. As we go into validation, we also seek to leverage knowledge gained recognizing importance of both development and manufacturing data.

At FUJIFILM Diosynth Biotechnologies we have completed over 20 successful Process Validation campaigns.  

We have supported Late Phase CMC related activities of six commercially approved products across our network. We bring that experience to our customers.