Stable and scalable protein formulations are in demand by companies interested in optimizing existing protein formulations, developing novel formulations, or understanding delivery modalities. Scientists in the biopharmaceutical industry are exploring the use of solid-state formulations as a solution for shipping intermediate or final drug products, as well as mitigating cold-chain storage and applications in developing nations. Capsugel develops formulations that are suitable for clinical and commercial production in current Good Manufacturing Practice (cGMP) facilities. Our work, which is rooted in our fundamental understanding of spray-drying and solid-state and solution formulation, is focused on the following areas.
Biotherapeutics Formulation and Development Services
- Formulation development using spray-drying, including at large scales (development and cGMP) and high containment facilities, with a focus on spray-drying and capsule-based delivery solutions
- Biologic, chemical, and physical characterization of biotherapeutics including antibodies and vaccines
- Dosage form development for oral, parenteral, nasal, and pulmonary delivery
- Scale-up and technology transfer, based on scientific and engineering fundamental understanding
Spray-Dried Biotherapeutics Offer Unique Advantages
Spray-drying is a proven processing technique particularly well-suited for the formulation of biotherapeutics. During manufacturing, formulations are exposed to mild temperatures for short residence times (< 30 sec) in the drying chamber and rapid drying kinetics solidify the particles in milliseconds. Spray-drying makes it possible to easily modify product properties by adjusting atomization and drying condition and is amenable to a wide range of formulation approaches.
Spray-dried biologics offer a number of important advantages. They are can be delivered via a variety of routes and are commercially viable because spray-drying is a continuous, easily scalable process with high product recoveries. Most significantly, spray-drying is suitable for use with a wide variety of biotherapeutics, including the following:
- Monoclonal Antibodies (mAbs)
- Designer Proteins
- Synthetic Peptides
- Nucleic Acid Therapeutics
Case Studies Highlight The Utility of Spray-Dried Biologics in the Marketplace
- Vaccine delivery in developing nations (Case Study 1);
- Supply-chain management to minimize storage of frozen solutions of API (Case Study 2);
- An alternative to lyophilization (Case Study 1 & 2); and
- High concentration reconstitution.