(418e) Large Scale Production of  Pharmaceutical Intermediates in the Flow Mode

In recent years, there have been significant efforts in the Pharmaceutical Industry to adopt continuous processing technologies to support the chemical/unit operation steps. Major drivers for developing flow processes and continuous manufacturing for specific steps include process safety issues, poor heat transfer, poor mass transfer in multiple phase reactions, presence of unstable intermediates, extreme reaction conditions requirements, and the need for short residence time. Since 2015, STA Pharmaceutical, a WuXi AppTec company, has established a leading continuous processing technology platform to support process R&D as well as plant scale production of pharmaceutical intermediates. The reaction types supported to date include cryogenic and room temperature lithiations, deprotection, photochemistry, ozonolysis, oxidations, dehydrations, coupling, cyclization, amination, and azide chemistries among other reactions. Flow steps included the above chemical steps as well as unit operations including phase separation, crystallization, filtration, and dissolution. The scale of the operations ranged from a few hundred grams to a few hundred kilograms under GMP and non-GMP modes. This presentation gives an overview of the continuous processing platform in STA followed by case studies illustrating the key benefits of this technology platform.