OCTOBER 202319Dr. Murugan obtained Ph.D in Chemistry from National Chemical Laboratory, Pune and pursued his post-doc at UT Southwestern Medical Center at Dallas. He is certified Six Sigma Black Belt with over 21 years of research experience in the pharmaceutical sector, he specializes in API process chemistry, showcasing exceptional scientific and leadership skills. His ability to blend classical wisdom with modern innovations equips him to address intricate challenges effectively.INDUSTRY INSIGHTSMANUFACTURING INNOVATIONS ACROSS INDUSTRIES: INSIGHTS FROM PHARMACEUTICAL EXPERTISEWhat are some significant changes in manufacturing related to technology that has enhanced in terms of efficiency, quality etc. affecting pharma and broader industries?In recent times, manufacturing has witnessed remarkable technological advancements that have greatly enhanced efficiency and quality, impacting not only the pharmaceutical sector but also various other industries. One notable transformation has been the extensive automation integrated into manufacturing processes. High levels of automation and continuous manufacturing have become prevalent, supported by the utilization of online tools for real-time process monitoring. Additionally, in the realm of research and development (R&D), there is a significant emphasis on Quality by Design (QbD) and enhanced process comprehension. Improved chemical process understanding and the integration of advanced instrumentation for material analysis have ushered in a new era of manufacturing precision.Furthermore, the industry has seen the emergence of cutting-edge software solutions, particularly in simulation, which has revolutionized the assessment of product quality, manufacturing efficiency, and output consistency. This has, in turn, reduced the reliance on manual labor and increased productivity. Moreover, the integration of artificial intelligence and machine learning software has gained momentum, influencing technologies like 3D printing, which have the potential to revolutionize final product manufacturing. These innovations collectively represent the substantial progress witnessed in the manufacturing sector.How have Route Design, Process Design, and Quality by Design improved safety and effectiveness in pharmaceuticals and beyond?The enhancement of safety and effectiveness in the pharmaceutical and industrial sectors through improved design processes and quality by design principles is a critical aspect. The focus here is on the optimization of manufacturing pathways, especially in the pharmaceutical industry. This involves streamlining chemical steps, minimizing intermediates, and selecting high-quality raw materials. By employing quality by design principles, the process is refined to identify optimal operating methods. In route design and process design phases, there has been greater emphasis on green chemistry. The metrics like atom economy and process mass intensity are routinely used to measure the greenness of the manufacturing processes. The goal is to achieve consistent quality, yield, and minimal waste in the production process.What are the challenges and opportunities in developing and manufacturing complex generics, and how your experience has contributed to overcoming these challenges?The increasing significance of complex generics in today's market presents both challenges and opportunities in the development and manufacturing of such products. The structural nuances and integrity of the products are not well defined. The study design for complex generics pose challenges due to the need for extensive clinical trials beyond simple generic products which also requires significant time and cost. Achieving equivalency standards in complex genomics is less straightforward. However, recent advancements in analytical techniques allow for better product characterization, understanding of nuances, and precise micro-level analysis. Effective communication with regulatory authorities is key to establishing product standards. Additionally, collaboration with experienced professionals in the field is Andiappan Murugan Vice President - R&D
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