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.
As the biopharmaceutical industry continues to evolve, the quality by design (QbD) holistic and proactive approach to drug development and manufacturing is transforming key processes. While QbD evolves from good practice to agency requirement, how can sponsors ensure that rigorous, scientific risk-based approaches are used to bring better and safer therapies to market faster?
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.
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.