Case Study


Performance Validation Of The Nucleo Scalable, Disposable Bioreactor With An Anchorage Dependent Cell Line

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Case Study: Performance Validation Of The Nucleo Scalable, Disposable Bioreactor With An Anchorage Dependent Cell Line

By ATMI LifeSciences

The increased adoption of disposable storage, containment and processing systems for biopharmaceutical manufacturing operations has provided numerous economic and efficiency benefits including reduced validation requirements, shorter turnaround times, elimination of cleaning regimes, faster set-up procedures and more flexible manufacturing platforms. Many life science companies have sought to extend these benefits to the field of cell culture in the form of disposable bioreactors and fermenters. The present study describes initial work undertaken to validate a new scalable, disposable bioreactor in this regard.

Microcarriers (both porous and non-porous) in suspension in a stirred-tank or in an airlift bioreactor are considered a desirable means of increasing the available growth area for anchorage-dependent cells. Unfortunately, such reactors generally are made of stainless steel, which requires extensive cleaning and sterilization operations after each batch, and can entail expensive subsequent control validations. To examine the performance and applicability of a disposable solution in this setting, the Nucleo™ bioreactor – collaboratively developed by ATMI LifeSciences, Pierre Guerin-Biolafitte and Artelis – was evaluated in the cultivation and infection of MDBK cells, immobilized in Cytodex-1 carriers, to produce an animal vaccine.

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Case Study: Performance Validation Of The Nucleo Scalable, Disposable Bioreactor With An Anchorage Dependent Cell Line

ATMI LifeSciences

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