GE Launches New Mfg Service for Viral Vector-Based TherapiesBy
GE Healthcare is launching a service, KUBio BSL2, that allows manufacturers to build a prefabricated modular manufacturing facility for viral vector-based therapeutics, including oncolytic vaccines and cell and gene therapies, and then to add production capacity.
KUBio BSL2 for viral vector-based therapies builds on the previous KUBio for monoclonal antibodies, an off-the-shelf manufacturing platform for biopharmaceutical products. This new platform adds a BSL2 environment specifically designed to contain a virus within the facility to protect the employees inside the facility and the public outside the facility.
KUBio BSL2 can be used to manufacture viral vector-based therapies, treatments that use viral vectors as antigen carriers for specific vaccines, or to deliver genetic material to target cells, such in the case of gene therapy. In gene therapy, viral vectors effectively protect the new gene from degradation while delivering it to the target cells that start using the new gene to perform its function to cure or treat a certain disease, according to information from GE.
KUBio BSL2 includes a facility that can be preassembled and shipped to a customer’s location, with a fully disposable manufacturing line that produces viral vector-based therapies and other recombinant products. GE says it can be constructed, assembled and fully fitted-out to cGMP standards faster than traditional stick-built facilities. It is structured to allow more kinds of products to be produced, such as different strains of the flu vaccine, or multiple viral vector-based therapies.
KUBio is based on single-use technologies, which allows customers to reduce labor and materials needed to perform cleaning and sterilization validation and qualification.
Source: GE Healthcare