In interaction with Industry Outlook, Andiappan Murugan, Vice President - R&D API, Troikaa Pharmaceuticals shares his views on some of the significant changes in manufacturing related to technology that has enhanced in terms of efficiency, quality etc. affecting pharma and broader industries, how Route Design, Process Design, and Quality by Design has improved safety and effectiveness in pharmaceuticals and beyond and more.
Dr. 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.
What 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 crucial. This multi-faceted approach, involving regulators and domain experts, ensures productive product development.
Tell us how can seamless technology transfer enhances product quality in both pharmaceuticals and other industries.
Seamless technology transfer plays a pivotal role in enhancing product quality across various industries, including pharmaceuticals. The essence of technology transfer involves the transmission of knowledge and processes to a manufacturing site, be it for a single component or an entire product line. To ensure its success, a robust process development is essential, encompassing a comprehensive grasp of critical process parameters. This entails a deep understanding of factors like heat transfer, mass transfer, reaction kinetics, and hydrodynamics within reactors.
Effective technology transfer necessitates advanced collaboration between research and development teams and manufacturing units. This collaboration facilitates a profound comprehension of the process intricacies and product specifics. Moreover, it aids in establishing a robust process, driven by data-based relationships between critical process parameters and key quality attributes. Statistical analysis, response surface methodologies and enhanced process understanding further contribute to a successful technology transfer.
Open communication and seamless collaboration are indispensable tools for ensuring efficient technology transfer, enabling manufacturing sites to adapt suitable equipment and absorb the new technology seamlessly.
Navigating evolving regulations is crucial. How do you align CMC strategies with dynamic requirements?
Navigating evolving regulations is crucial when aligning CMC strategies with dynamic requirements. Implementing regulatory requirements into the product lifecycle presents significant challenges. During development, the CMC strategy, which dictates control activation, is primarily guided by ICH and product-specific guidelines established at the product's inception. However, unexpected regulatory changes can pose roadblocks to manufacturing, as seen recently in the pharmaceutical industry.
To address these challenges, a deep technical understanding of the chemical process and the use of in silico software tools are essential. Not all products carry the same complexities, and regulators may accept justifications based on sound chemistry understanding. When facing challenges, it's crucial to comprehend the reasons behind regulatory changes, their impact on your products, and how they align with regulatory pathways. By gaining clarity on these aspects, many regulatory issues can be effectively managed.
What trends do you foresee shaping the future of pharmaceutical manufacturing? How can the industry stay ahead of these trends to maintain high standards of quality for consumers?
When considering the future of pharmaceutical manufacturing over the next five to ten years and the imperative to align with evolving trends while upholding high-quality standards, several noteworthy developments come to the forefront. Firstly, the automation of manufacturing processes has been gaining traction, although not universally adopted. In the coming decade, it is foreseeable that a substantial majority, potentially 80-90% of manufacturers, will have embraced automation extensively. This transformation will be further facilitated by the integration of AI and machine learning, simplifying automation implementation.
Continuous manufacturing is another pivotal trend. It has been gradually gaining prominence and is poised to revolutionize the production of pharmaceuticals. With its innovative potential, continuous manufacturing promises to enhance both product quality and productivity, making it a vital element in meeting industry targets.
Moreover, the adoption of online monitoring tools and 3D printing will significantly impact quality control and production efficiency. These technological advancements are poised to play a vital role in achieving industry objectives, potentially extending to the point where AI-controlled processes yield products directly from 3D printers. Overall, these trends represent an exciting trajectory for pharmaceutical manufacturing, promising increased efficiency, quality, and innovation to meet the needs of patients and consumers.
