Use of a disposable tangential flow filtration skid to manufacture monoclonal antibodies

BIOT 477

Harish Santhanam, santhanam_harish_k@LILLY.COM, Bioprocess Manufacturing, Eli Lilly, Lilly Technology Center, Drop Code 5613, Indianapolis, IN 46285
The use of disposable skids in downstream operations has many advantages. Ease of cleaning, flexibility and lack of capital expenditure being some of them. There is also an operational trade off with the use of disposable systems. The unit operations that utilize disposable systems become less automated and more operator dependant. There is less control over the processing conditions and there is an inability to monitor and acquire data that might be useful to troubleshoot the unit operation. A good strategy to overcome some of these drawbacks is the ability to use disposable systems with the capability to control and collect data. This presentation will outline the technologies used to optimally operate and control a disposable tangential flow filtration skid. The technologies used will enable data historian collection and analysis in a manufacturing environment without sacrificing the advantages of using disposable systems.