The pharmaceutical industry has been increasingly focused on the formulation of vaccines and biotherapeutics, especially in regard to manufacturing by spray-drying. Spray- drying is being pursued as an alternative to lyophilization for biotherapeutic formulations, due to the inherent robustness of the technology, the minimal amount of drug product required for formulation and process development, and the gentle processing nature of spray-drying biopharmaceuticals. Specific interest in this area has been focused on solid-state stabilization for compound storage, high-concentration protein processing, and parenteral or inhalation delivery.
This webinar will discuss approaches used at Bend Research to design, assay, and manufacture spray-dried powder formulations containing proteins and nucleic acids. Case studies will be presented that highlight work we have performed in this area. Formulation design and spray-drying process parameters will be discussed with a focus on target product specifications. The utility of solid-state characterization tools such as differential scanning calorimetry, vapor sorption, and x-ray diffraction will be presented as well.
Jeff Breit, Ph.D., Director of Inhalation Technology, Bend Research Inc.
Jeff Breit is responsible for inhalation drug delivery, biotherapeutic development, and formulation technologies. He previously held the positions of project leader and research scientist at Bend Research.
Dr. Breit earned his Ph.D. in pharmacology form the University of South Alabama, while working in the Center for Lung Biology. His doctoral work focused on gene regulation involved in pulmonary hypertension. Dr. Breit performed his postdoctoral work at Roche Pharmaceuticals in Palo Alto, California, where he focused on the genetics of complex disease states.
Dr. Breit has been with Bend Research since 2007.
Devon DuBose, Senior Research Engineer, Bend Research Inc.
Devon DuBose’s responsibilities include spray-drying development and scale up for pre-clinical and clinical projects, and transferring spray-drying processes into a current Good Manufacturing Practice environment. He also has expertise with special spray-drying projects for biologics and inhalation.
Mr. DuBose has been with Bend Research since 2007. He graduated with a B.S. in chemical engineering from Oregon State University and is a registered professional engineer in the State of Oregon. Mr. DuBose has three U.S. patents pending.
Who Should Attend?
People in the Pharmaceutical Industry interested in learning more about the benefits of spray-dried dispersions, solid dosage form formulation and process development
Bend Research is a leading independent scientific development and manufacturing company. For more than 35 years, our multidisciplinary teams have pioneered and advanced technologies to solve our clients’ most challenging technical problems.
Our capabilities include drug-delivery technologies such as spray-drying, hot-melt extrusion, and controlled release, as well as inhalation and biotherapeutics development. Spray-drying can be applied to a number of key biotherapeutics including peptides, proteins and virus-like particles (VLPs) for pulmonary delivery, DNA/RNA, and proteins for parenteral delivery. Bend Research offers process development and cGMP manufacturing capabilities to produce spray-dried dispersions. Our spray-drying methodology minimizes the use of valuable active Pharmaceutical ingredient (API), shortens process-development timelines, and ensures scalable processes and particles.
We are passionate about high-quality science and engineering, and use our deep understanding of science and engineering fundamentals to drive clients’ biotherapeutic production to higher levels. Bend Research employs nearly 300 people and has six state-of-the-art facilities located in Bend, Ore.