Technical Director, Concept Life Sciences
Is Your API Ready for GMP Scale Up?
Developing a small molecule active pharmaceutical ingredient (API) is often a risky process. Reaching the goal, be it first in human studies or commercial manufacture, requires data and material without incurring unnecessary delays or impact on costs. Therefore, it’s important to start thinking about process steps and scalability early.
How To Stop Good Pharmaceutical Formulations Going Bad
Selection of the appropriate techniques and assays, and their application in well-managed analytical programs, can simplify the process of deformulation and ensure a speedy route to market.