Fujifilm Diosynth Biotechnologies is an industry leading biologics contract development and manufacturing organisation.
Project Brief
Fujifilm Diosynth Biotechnologies is an industry leading biologics contract development and manufacturing organisation. The industry has extensive experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules expressed in a wide array of microbial, mammalian, and insect systems.
In 2013, Fujifilm Diosynth Biotechnologies was in the need of fully validated cold store to be delivered, installed and working by March 2014. To store more raw materials at 2°C – 8°C for their expanding client base.
Challenge
One main challenge for CRS Pharma Solutions was the restriction on time.
Fujifilm Diosynth Biotechnologies needed an update on their cold storage. As they were using normal sized fridges to store products, catering to the new clients demands would require an unreasonable number of fridges. Therefore, larger storage containers that stored products at 2°C – 8°C were needed and fast.
CRS was contacted in December and was determined to help Fujifilm Diosynth Biotechnologies. The cold store had to be built, installed, qualified and ready for use by the end of March.
Solution
CRS approached the project by manufacturing their cold stores on-site. This prevented the project from being held up due to other suppliers. The Cold Store was calibrated, validated and tested on-site at CRS, by our expert, in-house validation team.
This allowed CRS Pharma to deliver a fully validated and tested cold store to Fujifilm Diosynth Biotechnologies, complete with all of the IQ, OQ and PQ documentation required and temperature mapping. This prevented the extra 2-3 months of time that it would’ve taken if temperature mapping and validation was completed after delivering to Fujifilm Diosynth Biotechnologies.
The cold store was mobile and could easily be adapted to suit the needs of the industry. Fujifilm Diosynth Biotechnologies didn’t have to extend their building to facilitate it and could simple be moved around the premises.
Results
The 40ft Pharmagrade Cold Store was installed and ready for March. The temperature profile of 2°C – 8°C now allows the storing of raw materials for Fujifilm Diosynth Biotechnologies’ new customer.
