Process Chemistry: the progress of a chemical entity from conception to commercialization

Special

In these sessions, Dr. Mukund S. Chorghade will discuss the pivotal role played by Process Chemistry / Route Selection in the progress of a chemical entity from conception to commercialization.

Number of sessions: 6

The API business demands cost effective intermediates and as a result the industry has become too dependent on overseas manufacturers. During COVID-19 pandemic this dependency has heightened sensitivities regarding availability of critical medicines in the United States, United Kingdom and in many other locations around the world. Such heavy dependency has surfaced serious concerns about national security, public health and the leadership position of the US / UK in pharmaceutical industry.

The fundamental requirement for establishing such self-sufficiency is to establish cost-effective and environmentally friendly options for manufacturing intermediates / API. Overseas manufacturing of APIs/intermediates primarily utilize old processes established over two to three decades ago. Apinovo Pharma Innovations, Inc intends to develop novel proprietary processes that will enable cost-competitive and environmentally friendly manufacturing of pharmaceutical intermediates and APIs.

The medicinal chemistry routes for synthesis are usually low yielding and are fraught with capricious reactions, cryogenic temperatures, tedious chromatography and problems in scale-up to multi-kilo and multi-ton levels. Considerable research efforts have to be expended in developing novel, cost efficacious and scalable processes and seamlessly transferring these technologies to manufacturing operations. These principles will be exemplified by process development case studies on a variety of pharmaceutical moieties such as anti-epileptic, anti-obesity and an anti-asthma drugs.