Siva Sankar Mahamkali, Director at Aragen Life Sciences, stands as a beacon in biopharmaceutical manufacturing, scale-up, and technology transfer. With over two decades of experience, his expertise spans CDMO and commercial manufacturing environments. Mahamkali has been pivotal in operationalizing a cutting-edge biomanufacturing facility in Bengaluru and spearheading a $30 million bio-manufacturing site in India.
His proficiency in drug substance manufacturing, facility design, and operational management highlights his comprehensive grasp of the industry’s economic and regulatory dimensions, making him a respected figure in biopharmaceuticals on a global scale. In this exclusive interview with Raja Aditya of NSH, Mahamkali discusses leveraging CDMO technologies for biopharmaceutical advancement.
Mr. Sivasankar Mahankali, could you provide an overview of your professional background and experience?
I am Sivasankar Mahankali, with over 25 years of expertise in biopharmaceutical manufacturing, particularly in scale-up and technology transfer within both CDMO and commercial production settings. Currently, I serve as the Director of Aragen Life Sciences, where my role encompasses overseeing drug substance manufacturing and the operationalization of advanced biomanufacturing facilities. My career has also included pivotal roles such as the Plant Head at Syngene International, and notable positions at Panacea Biotec Ltd and Dr. Reddy’s Laboratories. Academically, I hold a Master of Science in Biotechnology from Acharya Nagarjuna University.
What are the primary regulatory challenges currently facing biosimilar development?
In biosimilar development, understanding and integrating regulatory requirements and expectations from the outset is crucial. When developing a product, it’s essential to align with the stringent guidelines set forth by leading regulatory bodies such as the USFDA and EMA, regardless of the initial market launch location. This alignment ensures that all aspects of the product lifecycle adhere to these high standards, facilitating smoother regulatory review and approval processes.
I emphasized in my recent conference presentation that even academic institutions should be well-versed in these regulatory expectations to prepare data that meets these standards from the beginning. By targeting the highest regulatory benchmarks, like those from ICH, EMA, and USFDA, we enhance our product development and manufacturing processes, ensuring that our products are developed efficiently and can be brought to market in a timely manner. This strategic approach not only simplifies the development cycle but also streamlines the approval process, allowing us to meet our production timelines effectively.
What innovative approaches do you believe will most effectively address the scientific and logistical challenges in biopharmaceutical development?
In my perspective, leveraging the technologies available within the CDMO sector is crucial for navigating the complexities of biopharmaceutical development. For instance, when developing bioassays or performing analytical characterizations, partnering with mature CDMOs in India can expedite product launches. As I have discussed previously, process intensification techniques such as membrane chromatography and computational fluid dynamics (CFD), alongside the use of models like AMBER bioreactors and miniature bioreactors, are pivotal.
These tools provide valuable data points that facilitate the progression from the developmental phase to the manufacturing stage. It’s essential for professionals in our field to consider and adopt these advanced technologies to enhance both the development and subsequent manufacturing processes.
