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.