Fujifilm Diosynth Biotechnologies is an industry leading biologics contract development and manufacturing organisation. The organisation 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.
Fujifilm Diosynth Biotechnologies won a new client and needed more raw material storage at 2°C – 8°C. They enlisted the services of CRS Pharma Solutions in December 2013 and needed fully validated cold store delivered and working by March 2014.
The main challenge for CRS Pharma Solutions was time.
Fujifilm Diosynth Biotechnologies were using stand-alone normal sized fridges but the quantities of materials the client suggested would be coming in would require an unreasonable number of fridges to store. Therefore they needed more storage for larger containers at 2°C – 8°C and they needed it fast.
Fujifilm Diosynth Biotechnologies placed the order to purchase the cold store at the end of December 2013 and the cold store had to be built, installed, qualified and ready for use by the end of March.
CRS manufacturer their cold stores on-site so the project wasn’t held up by the lead times of other suppliers. They also have an in-house expert validation team, which meant the cold store could be calibrated, validated and tested on-site at CRS before it was delivered to Fujifilm Diosynth Biotechnologies.
By carrying out the validation and temperature mapping before the installation, CRS were able to deliver a fully validated and tested cold store to Fujifilm Diosynth Biotechnologies, complete with all of the IQ, OQ and PQ documentation required. If the validation and testing happened after the cold store arrived at Fujifilm Diosynth Biotechnologies it would have taken 2 - 3 months to complete.
As the cold store was mobile, it meant the team at Fujifilm Diosynth Biotechnologies didn’t have to extend their building to facilitate it, it was simply attached to an existing building.
The 40ft pharma grade cold store with a temperature profile of 2°C – 8°C was handed over in March and is storing raw materials for Fujifilm Diosynth Biotechnologies’ new customer.
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