Abstract

Process Intensification - A Recent Trend in API Pharma Industries

Amin Ismaili, Technical Director, Alembic Ltd

All Pharmaceutical API industries are working in tight regulations boundaries of process & systems because of DMF process and IPR in regulated market. To sustain in regulated market with cost effective product and that too with same process chemistry is becoming challenge day by day. Only way out is to adopt technology change in same process chemistry and reduce production cost. This will not only increase profitability, but being a new trend it provides easy way out from IPR issues. Easily implementable technology change in present set up generally falls under the minor change category hence DMF amendment procedures are little smooth compare to chemistry change. We are in process of building new “Alchemy Engineering Science Institute (AESI)” at Vadodara - India. AESI is a novel approach to enable chemistry with technical aspect of engineering science for manufacture of any molecule. Development of different platform technologies and fitment to right chemistry can give dramatic results in terms of yield, quality and plant capacity enhancement. The whole concept is based on understanding of the process chemistry (science) so that most suitable processing technologies (process engineering) can be applied to execute the chemistry. AESI is completely focused on Process Intensification with a vision of green chemistry (zero effluent generation & zero solvent usage). We have expertise to develop different platform technologies with potential to produce large quantities of product in a small plant footprint – ‘A HOME FACTORY CONCEPT’