The First Kilograms Of GMP Drug Substance

At the point of selecting a lead compound for a drug development program, the supply of drug substance is on the critical path and required for all downstream activities. To ensure that the program progresses efficiently, it is vital that process development enables safe, economical, and rapid scale-up of drug substance manufacturing. To achieve this, drug developers require service providers with extensive chemistry capabilities who are focused on timely delivery of material and who can deliver drug substance manufacturing processes that can be scaled up at minimum risk.