Scaling-Up Virus Filtration
This project was undertaken for a contract manufacturer with two fully single-use GMP (good manufacturing practice) manufacturing operations on-site, employing a built-in contract process development lab that brings in and scales-up products for clinical trials, or other stages in the product life-cycle.
Parker domnick hunter was tasked with delivering a customized pumping solution for two existing SciFlex NFF systems used for viral filtration, which was comparable between process development and GMP manufacturing to facilitate technology transfer.
The customer’s process development group determined, after purchasing a Parker domnick hunter SciLog® SciFlex NFF unit, that the the operating flow rate range for their viral filtration process was much lower than the typical range of the pump on the SciFlex NFF unit.
Due to the size of the large pump purchased to achieve the high pressures needed for viral filtration, the flow rate initially chosen would only accomplish one exchange of all the fluid in the pump cavity every 30 minutes.
As a result of this extreme residence time, the pump dissipated a huge amount of heat into the protein product, completely denaturing it. The flow rate values specified by the process development group were not practical for the GMP production.
Developing a Solution
Parker domnick hunter provided two SciFlex NFF units, one for process development and the other for GMP manufacturing, each making use of two peristaltic-style pumps instead of one on the typical SciFlex NFF units. By delivering the same system but with different pumping capabilities, the client could accomplish more realistic filter sizing studies as well as eliminate variables presented by differing control logic.
The two previously purchased SciFlex NFF units were each retrofitted with two peristaltic style pumps, sized for their processes, which could accomplish the low flow rate and high pressure requirements of their viral filtration process.
Our solution brought the process development system’s flow rate capabilities up to overlap with the GMP system to give greater ease of technology transfer between the two development stages.