Many companies are adopting single-use technologies. This program begins with a workshop that showcases the cutting-edge implementation experience of CMOs and start-up companies. The complete program includes the latest case studies and strategies for single-use bioprocessing, including development of a fully disposable downstream train, disposable bioreactors and sensors, and other components. Validation for applications involving the reduction of extractables, leachables, endotoxins, particles, and other risk factors will be explained. A shared session with the colocated vaccine conference gives an in-depth look at the use of disposables in vaccine production. Vaccine manufacturers are cutting-edge early adapters of single-use technologies.
Hear how leaders in the field are increasing manufacturing flexibility, developing products faster and at lower cost, enabling multiuse facilities, accelerating turn-around times, and reducing validation efforts. Catch an FDA update on regultory review of single-use processes. Learn about the latest in prepacked columns and single-use downstream processing. Understand Genentech’s first-in-the-industry fully automated disposable TFF skid. Gain experience on implementation of disposable sensors, probes, and bioreactors. Find out how to improve speed and operational robustness and how to reduce consumable costs. Advance your projects by attending the preconference workshop.
“Universal, Rapid-Deployment, Single-Use Manufacturing: A Paradigm Shift for Vaccines” by Parrish M. Galliher (Xcellerex, Inc.): Vaccine manufacturing is undergoing a major shift. Recent successes demonstrate that rapid-deployment, universal, single-use production is enabling developers to prevent traditional bottlenecks affecting quality, cost, time, and supplies. Successes have demonstrated an ability to accommodate mammalian, insect, and microbial cultures that produce either subunit, live virus, attenuated virus, inactivated vaccines, or vaccine-like particles, including H1N1 “swine flu” vaccine. The presenter will review recent cases involving deployment of flexible vaccine manufacturing platforms.
“Optimizing Biomanufacturing Architectures: Flexibility, Agility, and Real-Time Advantage for an Unpredictable Future” by R. Barry Holtz, (president of G-Con, LLC): The Texas A&M University System (TAMUS) has initiated two large-scale biopharmaceutical manufacturing research and production facilities to demonstrate the concept of “flexible-by-design.” TAMUS seeks to transform biomanufacturing by optimizing the facility architecture and maximizing the utility of single-use bioprocess components to accommodate multiple clients, products, and technologies within a single facility. Combined with novel biomanufacturing platforms, single-use technologies can profoundly affect the future manufacture of commercial and defense-related biopharmaceuticals.
Featured Presentation from the FDA: “Single-Use Processes: Overview of Types of Data to Be Reviewed and Specific Areas of Concern” by Destry Sillivan (CBER).
“IBC’s single-use conferences are always a great opportunity to be updated on the latest industry trends.” —Jean-François Chaubard (director of industrial viral bulk production at GSK Biologicals in Belgium)