Antibody optimization has gone beyond achieving elevated protein titers and now focuses on understanding biologic and process variables that define protein quality. The integration of a holistic approach to biotherapeutic manufacturing incorporates a number of applied disciplines such as biology, engineering, process control, signal processing, and modeling in order to reduce the “black box” model of cell based protein production to an operational design space.
Bend Research is focusing on the development of an emerging process-development methodology that is based on applying novel and existing cell state monitoring technologies to existing bioreactor processes, coupled with applied mathematics, data-integration techniques and an understanding of biologic processes. This methodology offers an improved way to tune and manage cell and protein production processes through real time data integration technologies in order to optimize bioreactor processes.
The overarching goal of this work is to increase or maintain product quality across manufacturing sites and scales as well as to decrease overall variability and stream-line advanced R&D, pilot and commercial process definition. The application of our proposed methodology extends throughout the biopharmaceutical industry as well as industrial protein manufacturing and can be applied to both mammalian as well as microbial expression platforms. Ultimately, scientists interested in the reduction and application of big data to enhance control processes for bioreactors would likely benefit from this technology.
Jeff Breit, Ph.D., Director, Bend Research Inc.
Jeffrey Breit is a Director at Bend Research Inc., where he works in the fields of biotherapeutic drug development, inhalation drug delivery and formulation technologies. He has worked at Bend Research for 7 years.
Dr. Breit earned his Ph.D. in Pharmacology from the University of South Alabama, while working in the Center for Lung Biology. His doctoral work focused on defining genetic and molecular signaling processes involved in pulmonary disease. Dr. Breit performed his postdoctoral work at Roche Pharmaceuticals in Palo Alto, California, where he researched the genetics of complex disease states.
Brandon Downey, Technical Group Leader,Bend Research Inc.
Brandon Downey is a Research Chemical Engineer and Technical Group Leader at Bend Research, where he works on new technology development programs. His primary areas of expertise and responsibility include the development, scale-up, and integration of new manufacturing technologies into biotherapeutic production processes. He has worked extensively with dielectric spectroscopy probes applied to monitoring and control of mammalian cell culture processes. He earned his BS in Chemical Engineering from the University of Colorado, Boulder.
Who Should Attend?
Senior level professionals working with large molecules in the pharmaceutical and biotechnology industry worldwide
For more than 35 years, Bend Research has worked with clients to create value by advancing new medicines that improve human health and to solve their most difficult scientific and technical problems. This success is based on the company’s ability to develop, advance, and commercialize Pharmaceutical technologies, which grow from a solid base of scientific and engineering fundamental understanding. Bend Research is a leader in novel formulations, including SDDs and hot-melt extrusions, as well as controlled-release, inhalation, and biotherapeutics technologies.
Bend Research, now part of Capsugel’s Dosage Form Solutions business unit, has access to additional technologies, R&D capabilities and global manufacturing infrastructure for the advancement of client compounds from concept through clinical to commercial manufacture.
Bend Research has more than 250 employees based in four state-of-the-art facilities in Bend, Ore., USA, and is part of the global Capsugel network of 3,100 employees.