Scale-Up and Comparison Studies Evaluating Disposable Bioreactors and Probes - Process performance was comparable across all scales, and fiber optic sensors appeared interchangeable with conventional

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Scale-Up and Comparison Studies Evaluating Disposable Bioreactors and Probes
Process performance was comparable across all scales, and fiber optic sensors appeared interchangeable with conventional probes.


BioPharm International Supplements


Discussion

An optimized and transferable process was developed in the 2- and 5-L glass vessels by monitoring, controlling, and adjusting process parameters such as pH, temperature, and partial pressure of carbon dioxide (pCO2). The final process, a 14 day fed-batch culture with a day 2 feed of 12% of the working volume, a temperature shift mid-culture, and a pH drift after day 9 when necessary, was transferred to 50-, 250- and 1,000-L stirred-tank single-use bioreactors (SUBs). The performance of the optimized process was comparable across all scales, determining that the HyClone SUB was a suitable disposable bioreactor for manufacturing at Acceleron.

In addition to implementing disposable bioreactors, fiber optic dissolved oxygen probes and sensors were evaluated. Autoclavable probes from both PreSens and Finesse were compared to the traditional polarographic dissolved oxygen probes, and the disposable sensor from Finesse was also evaluated. Although additional studies need to be performed, initial results showed that the fiber optic technology used in the disposable sensors was comparable to the technology used in the traditional sensors and was feasible for implementation in Acceleron's biopharmaceutical manufacturing process.

Alissa Fernald is a cell culture engineer, Anna Pisania is a senior cell culture engineer, Esam Abdelgadir is a manufacturing associate 2, Jesse Milling is a manufacturing associate 2, Tod Marvell is a cell culture manager, manufacturing, and Bob Steininger is the senior vice president of manufacturing, all at Acceleron Pharma, Cambridge, MA, 617.649.9326,

REFERENCES

1. Trummer E, Fauland K, Seidinger S, Schriebl K, Lattenmayer C, Kunert R, et al. Process parameter shifting: Part I. effect of DOT, pH, and temperature on the performance of Epo-Fc expressing CHO cells cultivated in controlled batch bioreactors. Biotechnol Bioeng. 2006 Aug 20;94(6):1033–44.


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