11.15.20 -- Creating The Most Efficient Path To Market

When bringing a new drug to market, product development is typically aligned with the clinical trial schedule; therefore, as the patient pool grows, so does the amount of drugs needed for the study. Phase I calls for a small trial formulation using the easiest and least expensive manufacturing methods for just getting the drug to the patient.

Reducing the timeline from conception to Phase I trials can be especially challenging for emerging biotechs. Since many of them are completely virtual or have limited lab space capabilities, they often do not have in-house resources and capacity for formulation development. This in-house capability gap has led to tremendous growth in the CDMO market, as more of these companies are turning to outsourcing for early-stage development.

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.