Protein, Peptide and Vaccine Formulations
Optimizing existing formulations, developing new or novel formulations, or understanding delivery modalities requires stable and scalable biotherapeutic formulations. Capsugel Dosage Form Solutions strives to understand the stability and scalability challenges associated with biotherapeutics and develop solutions. We use 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. The formulations we develop are suitable for clinical and commercial production in current Good Manufacturing Practice (cGMP) facilities.
Our offering, which is rooted in our fundamental understanding of spray-drying, solid-state and solution formulation, is focused on the following areas:
- 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 based on particle engineering for oral, parenteral, nasal, and pulmonary delivery
- Enteric capsules for oral delivery and rapid pre-clinical development
- Scale-up and technology transfer, based on scientific and engineering fundamental understanding