Delivering higher output at lower costs -Why fully automated and continuous biologics manufacturing is the need of the hour, ET HealthWorld

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By Himanshu Gadgil

New Delhi: Counted amongst the top 10 pharmaceutical exporting countries in the world, India’s share of the global market has been on the rise, with Indian drug and pharmaceutical exports standing at $24.6 billion in FY2021-22. The low cost of production and strong research & development (R&D) capabilities of Indian pharma companies have been instrumental in making India’s drug and pharmaceutical exports competitive. Ranked third in terms of pharmaceutical production by volume, the Indian pharmaceutical industry counts generic drugs, vaccines, over-the-counter medications, contract manufacturing, biosimilars and biologics as its major segments, with the latter two providing the most potential for driving further cost competitiveness.

With the world focusing on more accessible healthcare rather than curative approaches at exorbitant prices, the demand for monoclonal antibodies and biosimilars is expected to witness exponential growth. While the Indian pharma industry has been growing at a CAGR of 9.43 per cent over the past decade, the domestic biosimilars market is expected to expand by a CAGR of 22 per cent till 2025 at least, with estimates stating that it could account for $12 billion by 2025. For the Indian pharma industry, which has been largely considered to be a leader in manufacturing generics, this presents an opportunity to scale up its R&D and manufacturing capabilities in a bid to churn out more complex biologics at affordable prices. In fact, with the country already being counted as the world’s largest supplier of generic medications and vaccines, India is well poised to establish itself as a global leader in terms of developing and manufacturing biologics and biosimilars in the near future.Towards this end, it will be important to not only explore biotech-based drug development and prioritize biosimilars and biologics, but also pursue revolutionary manufacturing technologies that can improve process efficiency and reduce the costs of production. A fully integrated and automated continuous biologics manufacturing process is one such approach that helps maintain stringent quality standards, while reducing the cost of manufacturing complex biologics and mAbs. Adopting this method also results in significantly smaller production facilities as compared with those using conventional manufacturing techniques, while GMP compliance ensures that manufactured products consistently meet high quality standards. Eliminating the need for large production facilities through compact operations results in a significantly lower carbon footprint, addressing the current need to build more environmentally sustainable production facilities that are kinder to the environment.Continuous manufacturing is also better suited to express human-engineered complex proteins such as bispecifics and fusion-proteins. In comparison, a traditional fed-batch process is less efficient in extracting the expressed protein and cannot compete with continuous manufacturing in providing higher yields and productivity for such modalities. With the apparent shift from monoclonal antibodies and the increasing need of complex proteins to achieve precision targeting and higher efficacies, adopting this technology has become imperative. What’s more, employing a fully automated continuous biologics manufacturing process minimizes the risks involved in pharmaceutical production, providing a safer environment for those working in production facilities. This is down to the utilization of robotic systems to create fully automated fill and finish lines, resulting in minimal human intervention as well as mitigating contamination risks.

With Indian pharma’s proven track record of developing and manufacturing quality, affordable and globally competitive biosimilars, the time is ripe for domestic players to switch over to more advanced manufacturing techniques and cement the country’s status as an innovative manufacturing hub. While the country’s focus on R&D and mass manufacturing vaccines has enabled India to fulfil around 60 per cent of the global vaccine requirement, the next leg of growth will undoubtedly be driven by domestically produced biologics and biosimilars. To achieve this, Indian pharma companies will have to comply with the higher quality requirements of countries such as the US, without losing on their cost advantage. Doing away with manual processes and conventional manufacturing practices and shifting towards fully automated and continuous biologics manufacturing will thus be an important step for the Indian pharma industry.

Himanshu Gadgil, CEO, Enzene Biosciences Ltd.

(DISCLAIMER: The views expressed are sole of the author and ETHealthworld does not necessarily subscribe to it. ETHealthworld.com shall not be responsible for any damage caused to any person/organisation directly or indirectly.)

  • Published On Jun 10, 2023 at 12:50 PM IST

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