The scientists and engineers at PacificGMP are experts with Wave Bioreactor Systems, Sterile Tubing Fusers and Sterile Tubing Sealers.
Cell culture is performed in pre-sterile plastic bags called Cellbags. Cellbag bioreactor chambers are single-use and satisfy all applicable GMP requirements for the production of human therapeutics. The Cellbag chambers incorporate the use of needleless sampling ports for sterile sampling. Cellbag chambers come with a variety of options including ports for filling and harvesting, in-process parameter measurements, thermoplastic tubing and internal perfusion filters.
The Cellbag is filled with media and cells and inflated to form a gas-impermeable chamber. It is then placed on a rocking platform and rocked to induce waves. The gentle wave motion provides excellent oxygenation and mixing with minimal shear forces. Once the culture is harvested, the used Cellbag is discarded and a new Cellbag can be immediately placed on the rocker for rapid turnaround. Single-use disposable bioreactors prevent cross-contamination and greatly reduce cleaning and validation time.
PacificGMP utilizes several sizes of Wave single-use bioreactor systems, with volumes from 100 ml to 500 Liters. The systems are run in batch, fed-batch and perfusion mode at any scale. When run in perfusion mode, a 500 Liter bioreactor system can yield 15,000 Liters or more per run.
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