Active Pharmaceutical Ingredient (API) Development Services

Active Pharmaceutical Ingredients, or APIs, provide the desired pharmacological effect of the drug. APIs that show promise in early stages of drug development must go through a rigorous testing and research phase to ensure the potential new treatment is safe, effective and can be manufacturing efficiently.

To support early-phase programs contract service providers offer a wide range of technologies and programs including: Development of new, scalable API route options; Route development and process safety assessment; cGMP Starting Material assessment and establishment of regulatory concept; Starting material and other raw materials sourcing and development; Polymorph screening & salt selection; Analytical method screening and preliminary stability profile; pre-formulation and preclinical supply; Selection of viable candidates; Gaining an understanding of critical material attributes (CMAs); Implementation of scale-up for quality in API manufacturing; Application of Quality by Design (QbD) by helping define the physicochemical design space.