Collaboration at work with FUJIFILM Diosynth Biotechnologies
When looking for a new fill-finish solution for its gene therapy manufacturing operations, CDMO FUJIFILM Diosynth Biotechnologies turned to isolator technology offered by Vanrx Pharmasystems. Thomas Page, Vice President, Engineering and Asset Development, was interviewed by the editor of The Medicine Maker about their experience working with Vanrx.
Some excerpts from the article:
How did FUJIFILM Diosynth and Vanrx come to work together?
We put together a venture team of senior people with various different areas of expertise, including quality, operations, commercial, engineering, and technical specialties. The team outlined what technologies and solutions we’d need to serve the market and decided that they would only consider isolator-based filling systems. We also wanted to be able to fill syringes, vials, and cartridges. The team opened discussions with a few different companies and then did a really deep failure mode and effects analysis (FMEA) dive to understand the ins and outs, the hazard pathways and the risk controls with different approaches within the industry. We scored each vendor and Vanrx scored twice as high as the next closest competitor, so the choice of who we should work with was very clear. We chose to use the company’s SA25 Aseptic Filling Workcell.
We have found that we are a good match in terms of how we like to work and our ultimate goal: to improve patient outcomes and patient access.
What are the benefits of Vanrx’s SA25 Aseptic Filling Workcell?
We have used the system for numerous fills for different live viral agents. We chose the system based on minimizing risk to the patient, as well as minimizing product loss. We have been working through several different iterations of components for a client to screen different approaches to filling – taking advantage of the fact that the unit does not have a hazard pathway that involves contact surfaces. All of the components are held by the nest; for example, there is no stopper bowl. This allows us to take earlier developmental material and fill it into an array of components, performing screening efficiently and giving the client the best primary container possible. The elimination of gloves has also been a bonus.
I think this type of technology is very beneficial for manufacturers and regulators alike. Simple designs that eliminate whole hazard pathways are easier to regulate, easier to understand – and reduce risks to the patient by many orders of magnitude.