Emerging reaction technologies in pharmaceutical development: Challenges and opportunities in electrochemistry, photochemistry, and biocatalysis

The challenges and opportunities of developing API manufacturing processes continue to grow. Molecular complexity of APIs is increasing, process development times are contracting, and there is a need to make processes greener, more efficient, and less costly. At the same time, emerging chemical technologies provide considerable opportunity to help address these challenges. Given that these are industry-wide challenges, the Enabling Technology Consortium (ETC) Novel Chemistry Reaction Environment Working Group seeks to realize the benefits of these novel technologies in manufacturing routes by developing solutions that bridge the gap from the bench hood to the manufacturing floor. After a prioritization exercise, the Working Group has focused on electrochemistry, photochemistry, and biocatalysis as technologies that the Working Group seeks to impact. In this perspective, members of the working group reflect on opportunities and challenges related to bringing these technologies to a scale-up-ready state, with the purpose of aligning the direction of technology development among academic labs, equipment manufacturers, and industry partners. In this article, we provide a viewpoint on what issues need to be addressed in these technologies from scalability, safety, and quality perspectives.