Changes in the bioprocessing market demand new ways of thinking. The industry needs smart solutions for easily scaling up or down production. Financial and production risks must also be minimized while adhering to strict demands from regulating bodies.
To meet these changing demands, GE Healthcare Life Sciences offers a range of flexible solutions to help biomanufacturers deal with complexity:
GE BioPark campus
Forward-thinking organizations always strive to stay at the leading edge of the biopharmaceutical market. With a shared infrastructure, GE BioPark pivots from traditional production models by offering a fast-to-market solution with reduced costs.
The GE BioPark concept provides clear advantages with a GE-supported infrastructure. A manufacturer can reserve a space in BioPark for a defined period and exercise the option only if and when needed. In addition, they can dramatically decrease financial risks associated with initiating expensive facility development when the outcome of the biopharmaceutical is uncertain.
GE BioPark complex incorporates four distinct KUBio™ biomanufacturing facilities that will operate independently and be customer owned and managed.
GE will own and manage:
- Media and buffer hydration facility
- Central utility building
- Warehouse
- Administration building
- Support services
KUBio biomanufacturing facilities
The KUBio prefabricated biomanufacturing facilities reduce time-to-market, which delays the need to make critical capacity decisions early in the drug development cycle. With a history of successful installations worldwide, this comprehensive solution provides proven technical expertise and in-country assistance to resolve the unexpected.
Substantially reducing costs and set-up time, biomanufacturers can choose a flexible, prefabricated current good manufacturing practice (cGMP) biomanufacturing facility with a configurable production line that future-proofs capacity expansion, improves operational efficiency, and minimizes infrastructure.
Investment in a traditional biomanufacturing facility is typically made years ahead of US Food and Drug Administration (FDA) approval. At that point, the molecule’s success rate is undetermined.
With KUBio, the manufacturer can wait until after Phase III clinical trials, when the success rate is more assured, and still be market-ready for when approval is given.
The individual modules for a KUBio facility are produced in a controlled environment, assuring excellent quality. While each module is designed to your specific requirements, preparations can be made concurrently at the planned site for the facility’s arrival. With GE support, it all comes together onsite, on budget and on time.
FlexFactory™ platform
With a FlexFactory manufacturing platform, both upstream and downstream bioprocessing can be optimized while reducing operational costs. The platform offers faster deployment, multi-product processing and accelerated production with flexible, scalable processes.
Single-use technology enables the manufacturer to rapidly respond to changing capacity needs. It reduces changeover time between batches and minimizes costs associated with cleaning-in-place (CIP).
Existing facilities, new facilities, dedicated single-use platforms, and hybrid platforms all benefit from integrated unit operations. With single-use technology, individual processes can be modified as production needs change, enabling rapid modification of your production line.
Automation provides the client’s biomanufacturing facility with centralized process monitoring and control, data management and trending, as well as a 21 CFR Part 11 compliant-ready solution. The FlexFactory design can be integrated with an automation scheme that helps drive operational efficiency at a process, plant, or global facility level.