GE Healthcare: The Next Cell and Gene Therapy Manufacturing Giant?

In separate press releases on April 11, 2017, GE Healthcare announced the company is beefing up its bioprocessing capabilities. The company purchased Asymptote, which specializes in cold chain technology for cell-based therapies, and will continue its partnership with Zenith Technologies, which offers automation solutions and process integration.

According to the release, the software systems from Zenith will play “a central role in manufacturing coordination, control, and documentation,” and will help GE in its endeavors to incorporate continuous monitoring and maintain batch-to-batch consistency in its FlexFactory and KUBio manufacturing offerings. "Automation enables fewer manual operations in the biomanufacturing process and provides real-time data to customers to evaluate their operations more quickly, including batch data and investigations," Jan Makela, general manager, bioprocess, GE Healthcare Life Sciences told BioPharm International. "This greater efficiency can help reduce the non-productive time between production."

When this publication asked Makela if the automation would be applied to all GE products, he said, "Zenith will be involved in providing ongoing support and customer-specific upgrades where required, as part of GE’s existing commitments to the large and growing base of FlexFactories. Zenith will be working, going forward, on developing the breadth of our automation offering for future customer needs, and also the connectivity to other IT systems used in production environments." According to Ger Brophy, general manager of GE Healthcare’s cell therapy business, GE healthcare supports more than 100 clinical stage companies between its various product lines. 

The Asymptote acquisition will allow GE to enhance its cryochain technology, which will better protect sensitive cell therapies using liquid-nitrogen-free controlled-rate freezers. The press release says Asymptote provides “pioneering technologies that challenge standard cell cryopreservation and thawing practices.” GE hopes the acquisition will help the company further industrialize the cell therapy industry, according to statements from Brophy. GE's customers currently rely on liquid nitrogen-based cryofreezing technologies, Brophy tells this publication, which can "inadvertently introduce contaminants and infectious agents compromising the quality of the final therapeutic product."

Asymptote’s web-based platform allows users to remotely standardize and monitor the freeze-thaw process of cell therapies across multiple sites. The improved visibility surrounding the status of the cellular products will help GE scale their phase shift activities with ease, the company says.

Brophy adds. "Cold-chain management is a requirement for the vast majority of therapeutic manufacturing processes, regardless of where [the facilities] are located. Even in proximal manufacturing approaches, retaining samples or being able to pause the production through a freezing step is often introduced. GE supports both manufacturing models, and find them both to be prevalent in the industry today."

The Asymptote acquisition and the Zenith investment are just the most recent investments from GE in regenerative therapy. Earlier in 2017, the company also invested in Biosafe SA, Vitruvian Networks, and BridGE@CCRM Cell Therapy Centre of Excellence, which are all support the manufacture of cell and gene therapies.

GE will use Asymptote (along with its other technologies) in Cellular Biomedicine Group’s facilities to help them develop stem cell and chimeric antigen receptor T-cell (CAR-T) manufacturing capabilities.

Dominating the industry
GE’s recent partnerships include the co-development of facilities with FujiFilm, Pfizer, BeiGene, and JHL. Through these partnerships, the other company has agreed to use GE technology (in part or in whole) to manufacture its products.

In 2016, GE also sold its rights to an inactivated yellow fever vaccine to PnuVax under the condition that PnuVax purchase a FlexFactory from GE to manufacture the product. In February 2017, the Austrian Centre of Industrial Biotechnology forged a three-year pact with GE to optimize the performance of GE’s Chinese hamster ovary (CHO) cell line.

It appears GE’s technology-both its legacy solutions and its recent investments in new bioprocessing products-is becoming more indispensable to various clients.

Source: GE Healthcare