Complex Molecule Development: What Should You Consider Early To Avoid Failing Later?

By Andreas Stolle, Ph.D., and Peter Poechlauer, Ph.D.

Innovations in science and technology over the last few decades enable scientists to create far more advanced pharmaceuticals for today’s industry. As a result, patients rightfully expect medication with fewer side effects and physicians anticipate new and better cures for formerly untreatable diseases. These expectations require new pharmaceuticals to offer an advantage over existing therapies, one that sponsor companies must be able to prove in clinical trials. However, they also increase the difficulties of drug development, due to the added complexity of the active pharmaceutical ingredient (API) and the delivery system needed for these drugs. 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.

Therefore, while the complexity of these molecules begins with their chemistry, any company entering this space is likely to discover the challenges extend well beyond that. Not understanding and preparing for them early in development could result in bottlenecks that significantly slow production and delay a drug’s time to market.