Disposable bioreactor for clinical cell and gene therapy
Getinge offers researchers a turnkey solution with the AppliFlex ST GMP, a state-of-the-art single-use bioreactor system specifically designed to bridge the gap between research and clinical production in the fields of cell and gene therapy and mRNA production.
Getinge's new AppliFlex ST GMP represents a significant milestone in the advancement of bioprocessing technology, providing researchers with a seamless, turnkey solution for transferring bioprocesses from laboratory research to clinical applications. This carefully designed single-use bioreactor plays a critical role in bringing cell and gene therapies to the market.
"The AppliFlex ST GMP builds on the proven success of the AppliFlex ST bioreactor, offering scalability and precise implementation of clinical phase processes. Available in a variety of sizes, this bioreactor system provides a comprehensive cGMP manufacturing solution without compromising efficiency and simplicity," says Sean Herdlein, Vice President Bio Processing at Getinge.
Getinge's solution includes consumables, tools, verification and GMP-compliant software to ensure a well-rounded solution for clinical researchers and manufacturers. The AppliFlex ST GMP is therefore suitable for the manufacture of clinical trial materials and clinical production.
"With over 40 years of experience in cGMP system qualification, we are proud to expand our portfolio to include lab-scale cGMP bioreactors to support researchers on their path to clinical success," Sean continued.
Tom van Arragon, Senior Product Manager Life Science at Getinge, adds: "With the introduction of the new consumables production cleanroom at our plant in Delft, the Netherlands, we are ready to grow together with our customers by producing the consumables that meet their production needs."
The AppliFlex ST GMP meets the requirements for GMP-compliant research and production environments and sets new standards for innovation and regulatory compliance.
Disclaimer: Getinge's GMP-compliant systems are intended for use in GMP-compliant production and research environments and are not intended as medical devices.
