GE Healthcare will equip G-CON’s prefabricated cleanrooms with its cell therapy and viral vector technologies in the latest expansion of its partnership.
The collaboration aims to incorporate GE Healthcare’s cell therapy and viral vector technologies and process design within G-CON’s prefabricated flexible cleanrooms (known as ‘PODs’) in efforts to speed up and offer flexibility to customers’ advanced therapy projects.
“This collaboration is unique because it provides our customers with an entire cleanroom infrastructure from a single source and will improve and accelerate cell therapy and viral vector manufacturing on a GMP Scale,” Greg Crescenzi, enterprise solutions leader at GE Healthcare Life Sciences’ Cell & Gene Therapy division, told BioProcess Insider.
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The two firms have been working together to create integrated, modular cleanrooms for some time, but this is the first move into providing technologies for the manufacture of cell therapies as well as lentivirus (LV) and adeno-associated virus (AAV) vectors, used as delivery vehicles for the growing gene therapy space.
“As the industry continues to evolve, we evaluate the needs of customers and determine the best ways to engage with our partners to deliver the technology our customers need,” said Crescenzi.
Maik Jornitz, CEO of G-CON Manufacturing, added “the commercialization of the cell therapy industry requires a paradigm shift in manufacturing, because of the highly individual and complex nature of the production process,” and this joint approach provides turnkey solutions and removes manufacturing bottlenecks.
Modular facilities
GE Healthcare itself has prefab offerings in the forms of its Flex Factory and KUBio platforms used for flexible manufacturing of biologic products. KUBio, for example, is based on single-use technologies and GE claims it can be constructed, assembled and fully fitted-out to current Good Manufacturing Practices (cGMP) standards in up to half the time of traditional builds.
According to Crescenzi, the joint offering with G-CON “is a small to large scale manufacturing solution between a Flex Factory and KUBio, which means that drug developers and manufacturers can purchase a fully functional production line and environment that can be housed in a warehouse type structure.”
Meanwhile, G-CON has also recently forged a deal with fellow bioprocess vendor Pall, which has incorporated its continuous bioprocessing and viral vector production designs, including automation and utility supplies, to G-CON’s POD units.