Finding a balance between a complex API, its formulation, and its synthesis requires equipment, knowledge, and processes more extensive than those typically required for traditional drug development. It also calls for collaboration across several teams in order to break down the silos that can interrupt the flow of open and clear communication.
Traditionally, the development of a small-scale synthesis for an active pharmaceutical ingredient (API) and its scale-up to meet the materials demand for clinical trial phases is a sequential activity that passes through multiple sets of hands. If, in the course of the development process, undesirable effects occur that negatively impact API scale-up, it can prevent a company from delivering a product with reliable quality and efficacy.
Once deemed an “experts only” approach to chemical synthesis, flow chemistry is a cost-efficient technique growing in popularity that can facilitate scale-up, improve product quality, and even address some of pharma’s biggest challenges, such as drug shortages and recalls.
The challenges for new drugs looking to enter the market are numerous and varied. But many are self-inflicted — especially in small molecule development. A dangerous perception persists that, aside from highly potent APIs, small molecule medications have simple process requirements. Having a solid understanding of the most common API challenges can help to avoid development delays, rework, or outright failure.