Methods Development, Design Analysis, and Testing of Novel Centrifugal Devices for Mammalian Cell Culture Harvest

Thermo Fisher Scientific is developing a centrifugal device to be used in the biopharmaceutical industry. The novel technology was used to remove cells from cell cultures, which produce drugs and medical treatments. The harvest process of removing cells is the first step towards product purification and is an important unit operation for ensuring high product yield. Since the device is a novel technology, methods to test and evaluate the performance of the centrifuge needed to be developed. Successful testing methods were developed in this work and were implemented on over 30 different centrifuge designs. Amongst these many designs, different operating procedures were developed that were unique to the design of the centrifuge. Cell cultures were often used as the testing material to evaluate the centrifuge designs, but an alternative testing material was developed to simulate cell cultures. This testing material consisted of cell sized microbeads that could mimic cell separation during centrifugation. To help visualize results of different operating conditions and parameters, a prediction model was developed to determine the operation window of the centrifuge. This can be used to help guide the application process of centrifuge