Inhalation therapy is an area of research focus at Bend Research. Our pulmonary drug delivery and nasal drug delivery technologies leverage more than 15 years' experience in formulation development and particle engineering.
We have expertise in:
- Particle engineering
- Development of novel inhalation dispersion excipients
- Formulation and particle embodiments
- Equipment and scale-up
- Dry powder formulation development for biotherapeutics
- Capsule fill for dry powder aerosols
Bend Research provides feasibility and formulation identification for dry powder compositions of small molecules and biotherapeutics. We have a full scale-up train from mg scale to kg scale, cGMP manufacturing facilities, and capsule filling capabilities. Analytical, chemistry manufacture and control, stability, and in vivo studies are supported through our collaborator network.
Particle Engineering Experience
At Bend Research, we have the equipment, process and formulation know-how to develop engineered particles across a wide range of sizes and size distributions for a wide variety of delivery routes and applications. All approaches have been demonstrated as feasible through current good manufacturing practice (cGMP) manufacture.
Development of Novel Inhalation Dispersion Excipients
A critical factor in inhalation dispersion platform technology is the identification of safe excipients with high glass-transition temperatures (Tgs). Dextran and dextran-based materials provide an overlay of performance and precedented use in clinical studies. Using this approach, we have successfully formulated many different types of compounds including combination therapies, biotherapeutics and small molecules.
Formulation and Particle Embodiments
Lack of precedented excipients for inhalation and interest in combination therapies has led Bend Research to pursue multiple creative formulation concepts. All terminally utilize the spray-drying process to generate respirable powders.
Equipment and Scale-up
The spray-drying process leads to a scalable way to tune particle size to obtain highly efficient dry-powder aerosols. Bend Research has custom equipment designed to efficiently manufacture and collect particles of sizes and size distributions suitable for inhalation. The scale-up train delivers consistent product from material-sparing feasibility studies (milligram quantities) through large-scale manufacture (several kilograms) of clinical trial material.
Dry powder formulation development for biotherapeutics
There has been increasing interest in delivering biotherapeutics to the lung. Very often, a dry powder is ultimately desired and current lactose-based technologies are not appropriate. Using approved, precedented or novel excipients, Bend Research identifies formulations and a gentle spray-dry process that leads to stable dry powders with excellent aerosol performance. Our expertise in spray drying and custom equipment enables rapid material sparing formulation identification that can then easily be scaled to our GMP facility for toxicology supplies or clinical studies.
Capsule fill for dry powder aerosols
Very often in early proof-of-concept studies, it is desirable to rapidly begin clinical studies with a simple and commercially available
capsule-based dry powder inhaler. To support this, Bend Research has dry-powder capsule-fill capabilities to support stability, toxicology studies and Phase 1 clinical studies.
Download the PDF presentation below for an overview of our inhalation technology: