Breaking Barriers in Bioprocessing: An Interview with Himanshu Gadgil, CEO of Enzene Biosciences

With a rich background in biochemistry and extensive experience in the pharmaceutical industry, Himanshu shares insights into Enzene's journey, its innovative approach to biosimilars, and the strategic expansion into continuous manufacturing facilities, aiming to revolutionize the accessibility and affordability of life-saving medicines.

LL: Could you introduce yourself and share a bit about your background leading up to your role at Enzene?​

HG​: My journey in bioprocessing started with a PhD in biochemistry from the University of Tennessee. I then gained valuable experience at the analytical equipment company Waters Micromass before joining Amgen, where I focused on bioprocess development. In 2011, I returned to India, recognizing the significant need for cost-effective biosimilars in the country. This led me to work with various Indian pharma companies before seizing the opportunity to lead Enzene. At Enzene, we prioritize innovation and aim to address local and global healthcare challenges through technology-driven solutions.

LL: Could you elaborate on the motivation behind Enzene’s work and the role of innovation in addressing healthcare needs, particularly in India?​

HG:​ India, like many countries, faces significant healthcare challenges, including access to affordable medicines. Despite the presence of biosimilars in the market, affordability remains a major barrier for patients. Recognizing this, Enzene set out to disrupt the cost barrier through innovation. We saw an opportunity in continuous manufacturing technology, envisioning smaller footprints and higher productivity. By embracing innovation, we aimed to make life-saving treatments more accessible to patients in India and beyond.

LL: Continuous manufacturing seems like a game-changer. Can you explain how it works and its advantages over traditional fed-batch manufacturing?​

HG: Continuous manufacturing involves seamlessly integrating upstream and downstream processes, resulting in a smaller carbon footprintg coming from a smaller equipment footprint and higher productivity. Unlike fed-batch  manufacturing, continuous processes offer significant cost savings and efficiency gains. For instance, our continuous platform, EnzeneX 1.0, enables us to achieve high cell densities and lower cost of goods, making biosimilars and biosimilars more affordable for patients. Furthermore, our ongoing development of EnzeneX 2.0 and exploration of AI and process automation demonstrate our commitment to advancing this technology further.

LL: Your journey into continuous manufacturing is impressive. How do you see this expansion aligning with Enzene's broader strategic goals?​

HG:​ We aspire to be a global leader in biotech. Expanding into continuous manufacturing facilities, such as the one in New Jersey, aligns with our vision for global growth and innovation. By leveraging our early mover advantage, we aim to enhance our competitiveness and meet market demand more effectively. Additionally, continuous manufacturing allows us to cater to the evolving landscape of biopharmaceuticals, ensuring our relevance and impact in the industry.

LL: What challenges did you encounter during the development of the continuous manufacturing facility, and how did you address them?​

HG:​ Transitioning to continuous manufacturing posed several challenges, particularly in maintaining bioburden control across the entire process. We faced numerous setbacks and failures before achieving success. However, each failure provided valuable lessons, allowing us to refine our processes and plug potential gaps. Overcoming these challenges required perseverance, collaboration, and a commitment to continuous improvement.

LL: Your journey seems to highlight the importance of resilience in innovation. Looking ahead, how do you plan to stay at the forefront of this trend and sustain your competitive edge​?

HG:​  Continuous innovation is key to maintaining our competitive edge. While our early mover advantage is significant, we must continue to enhance our platform and adapt to emerging trends. This includes further optimizing our technology, exploring new partnerships, and integrating advanced analytics and AI. By staying ahead of the curve, we aim to solidify our position as a global leader in bioprocessing.

LL: Your insights into the future of bioprocessing are certainly sound, how do you envision the role of India in the global pharmaceutical landscape, particularly in terms of innovation?​

HG​: India has made significant contributions to global healthcare through its expertise in manufacturing and generics. However, to truly lead in the industry, India must embrace innovation and address local healthcare challenges. By fostering a culture of innovation and investing in R&D, India can elevate its position and drive meaningful change in the global pharmaceutical landscape.

To conclude, Gadgil's journey from academia to leading Enzene exemplifies the power of innovation in addressing healthcare challenges. With Enzene's pioneering efforts in continuous manufacturing, the company is poised to revolutionize the accessibility and affordability of life-saving medicines, both in India and on a global scale. As India continues to embrace innovation, its role in the pharmaceutical landscape is set to expand, driving positive change and improving healthcare outcomes worldwide.