Our contract development and manufacturing (CDMO)
division is a leader in the development of long-acting depot injections—including bioabsorbable microparticulate systems and in situ forming gels. From initial lab assessment and pre-formulation to formal drug product development, scale-up, GMP clinical trial production, and commercial manufacturing, we have the capabilities and expertise necessary to accelerate your depot injection to market.
Our team has experience with a broad range of active pharmaceutical ingredients (APIs) and polymers, including poly(lactic-co-glycolic acid) (PLGA) and polylactic acid (PLA). We understand how to formulate and characterize these polymers to support Q1/Q2 sameness evaluations of generics and the development of new chemical entities (NCEs). We are polymer agnostic and have preferred relationships with the world’s leading biodegradable polymer suppliers.
Our techniques for microparticle or microsphere formulation and drug product manufacturing can be applied to both small and large molecules. They include:
- Emulsion – solvent evaporation
- Emulsion – solvent extraction
- Spray drying
- Coacervation/phase separation
- Jet milling
- Augmented drip casting
We are skilled in the formulation, manufacturing, and analytical characterization requirements for microparticle products and our team is motivated to progress your product to the desired endpoint.