Whether you are developing a process de novo, transferring an existing process for optimization, or locking a process in preparation for Process Validation, selecting the right CDMO partner will be a key decision in the life of your product. Strategic partnering with a CDMO can be driven by the clinical phase of your molecule(s), the timelines you are trying to meet, the type of molecule you are developing, your immediate versus long terms goals, and other factors that guide your selection criteria.
Our Process Development Philosophy
At FUJIFILM Diosynth Biotechnologies our Process Development Philosophy is driven by designing processes that result in having phase appropriate product controls that will result in successful process execution during GMP Manufacturing. We do this by applying a series of Risk Assessment tools that match increases in process knowledge. What do we know about this molecule? If there is an existing process, what do we know about it? Has the process been scaled up? Was it designed with manufacturability as an end point?
Working together as partners with our customers, we leverage our extensive experience with a wide range of molecules, to reduce risks due to gaps in knowledge and focus resources and attention on New, Unique, and Difficult elements (NUDs) as the Process Development program plan is developed.
Understanding where you are in the development stage is also important. Some of the early evaluation questions that you may have include:
- Do I have a robust cell line/strain?
- Will I be able to get early material for Proof-of-concept/ Toxicology Studies?
- Are my titers and process yields in line with the clinical patient supply goals?
- Do I have a process that will support long term sustainable manufacturing?
- Do I have Analytical Methods in place that will support my Product and Process Development goals?
- Do I have all that I need for a successful IND application? For a BLA?
- What aspects of Process Development are on the critical path?
What to look for in a Process Development Partner
As you evaluate CDMOs, careful consideration should be given to the track record and capabilities of your partner of choice. FUJIFILM Diosynth Biotechnologies’ track record in delivering successful programs to our partners is well established with over 280 programs with a wide array of molecules at all stages of development. As a partner to our customers you have access to this experience.
Our Process Development experience includes the development of processes for molecules expressed via microbial fermentation (e.g., E. coli, P. pastoris), cell culture systems including CHO, HEK, Vero, MDCK, EB66 and insect cells, and from transgenic sources.
The FUJIFILM Diosynth Biotechnologies Global Process Development Team has expertise in Upstream and Downstream Process Development, Scale-up, and Validation. We understand that the requirements for Early Phase programs are quite different; both from a development and regulatory standpoint, than Late Phase Program. Our goal is to work with you to provide you with a Phase appropriate program plan that will get you to your next clinical stage economically and within your planned timeline.