11.22.22 -- Complex Injectables Development & Manufacturing: Considerations And Choosing A CDMO

Manufacturers are taking innovative approaches in designing and developing formulations to reduce pill burden and improve safety and efficacy of drug molecules. Explore the decision for selecting the right and most suited technology for formulating a complex molecule.

As a product transitions from preclinical development to clinical development, the manufacturing process takes on a greater role in the project's overall success, which is particularly difficult for emerging pharma companies that require greater expertise in the engineering, regulatory, and quality aspects of manufacturing the drug product.

The advantages of nanosuspension dosage forms include improving bioavailability and API stability, eliminating food effect, increasing drug loading, eliminating cosolvents, masking bad API taste, better dose flexibility and accuracy, and easy swallowing for pediatric or geriatric populations.

The right CDMO partner will have specialized technologies for complex injectable development along with the equipment, facilities, and operations to adopt GMP practices within a “laboratory setting.” They will also have greater flexibility regarding changes, timing, and the cost for successful manufacture of complex injectables in early-phase development of therapeutic drugs.

The increasing prevalence of chronic disorders, growing demand for self-administration and home healthcare, increasing focus on pediatric and geriatric patients, and the increasing demand for minimally invasive surgeries have further fueled the growth of the long-acting injectable drug delivery market.

Due to a lipid’s unique properties and excellent biocompatibility, lipid nanoparticles are used in pharmaceuticals, nanomedicines, vaccines, nutritional supplements, and diagnostics by different routes of administration, such as oral, topical, pulmonary, and parenteral injection.