Engineered Particles for Inhaled Biotherapeutics: Considerations in Process and Formulation

The number of pharmaceutical biological compounds in development and on the market is rapidly expanding, and this trend includes developing biotherapeutics to be delivered through inhalation. However, popular delivery systems, such as nebulizers, and often-used excipients, such as lactose, can present delivery, incompatibility, stability, and other issues. In response, spray drying has been used to manufacture and deliver inhalable engineered particles using excipients other than lactose.

In this presentation, we will outline important aspects of the spray-drying process and highlight formulation and process parameters that dictate a scalable, stable, and efficacious inhalable drug product.

Specific topics to be discussed include:

• How spray drying can rapidly screen and minimize active pharmaceutical ingredient (API) use during formulation development, excipient screening, and manufacturing process determination
• Creating and testing inhalable spray-dried engineered particles for biotherapeutics with a focus on particle and protein stabilization during formulation design and manufacturing
• Importance of particle quality attributes including crystalline character, water content and water uptake
• How successful creation of spray dried particles with a mass median aerodynamic diameter (MMAD) suitable for inhalation and deposition into the lung is tied to the manufacturing process and API formulation
• Tools used to screen and characterize powder particle properties

Over the past 18 years, Bend Research has successfully developed and applied spray-dried dispersion (SDD) technology to more than 400 compounds, including hundreds of compounds in in vivo tests and clinical trials and in various modes of delivery. This expertise in SDDs is now being implemented in the successful development of inhalation therapies.

People in the Pharmaceutical Industry interested in learning more about the benefits of spray-dried dispersions

Jeff Breit is the director of inhalation technologies at Bend Research, and is responsible for inhalation drug delivery and biotherapeutic technologies. He previously held the positions of project leader and research scientist.

Dr. Breit earned his Ph.D. from the department of pharmacology while working in the Center for Lung Biology at the University of South Alabama. His doctoral work focused on gene regulation involved in pulmonary hypertension. Dr. Breit performed his post-doctoral work at Roche Pharmaceuticals in Palo Alto, Calif., where he focused on the genetics of complex disease states.

Dr. Breit has been with the company since 2007.

Devon DuBose is a research engineer at Bend Research Inc. His 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 processes that involve biotherapeutics, inhalation products and hot process manufacturing.

Mr. DuBose has been with Bend Research since 2007. He graduated with a B.S. in chemical engineering from Oregon State University. Mr. DuBose has one U.S. patent pending.

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 provides formulation and dosage-form support, assists in process development and optimization, manufactures clinical-trial quantities of drug candidates in its cGMP facilities, and advances promising drug candidates from conception through commercialization. Bend Research is a leader in novel formulations, including SDDs and hot-melt extrusions, and controlled-release, inhalation, and biotherapeutics technologies.

Bend Research has more than 245 employees based in four state-of-the-art facilities in Bend, Ore., USA. For more information about Bend Research, please contact Phoenix Ivers via email at Phoenix.Ivers@BendResearch.com, by phone at 541-382-4100 or 800-706-8655, or visit our website at www.bendresearch.com.