India’s biotech growth story is now a manufacturing story: G Balaji

How do you see India’s biotechnology sector evolving as it moves from scientific breakthroughs towards large-scale commercial manufacturing?  We have witnessed a remarkable transformation in India’s biotech industry over the past decade, driven by the expansion of the start-up ecosystem and the emergence of high-value opportunities across the life sciences. Biosimilars, in particular, have become an important part of India’s growing biomanufacturing capabilities. The opportunity now extends well beyond healthcare, with increasing demand across food and nutrition, sustainable materials, bio-based chemicals, and precision fermentation.  As these sectors mature, manufacturers will need to expand production capacity while maintaining quality, consistency, and cost competitiveness. That requires industrial-scale execution. Companies that can scale reliably, meet global quality standards, and bring products to market faster will have a significant advantage in international markets. India is well placed to combine its strong scientific talent base with advanced digital manufacturing and automation capabilities to realise the broader potential of its life sciences sector.  Manufacturing excellence is becoming just as important as scientific innovation in determining long-term success.  What are the biggest operational challenges biotech manufacturers face when scaling production, particularly in maintaining consistency, quality and regulatory compliance?  One of the biggest operational challenges in biomanufacturing is maintaining consistency as production scales. Even small deviations in critical process parameters can impact yield, product quality, and batch-tobatch reproducibility, leading to costly investigations, rework, or production delays.  The challenge is compounded by stringent regulatory requirements, where every recipe modification, process adjustment, or equipment change must be fully documented and traceable. Manufacturers need a clear audit trail showing what changed, who approved it, and how it affected production. At the same time, they must manage vast amounts of process and quality data while maintaining data integrity and end-to-end traceability. Successfully scaling production therefore requires more than adding capacity; it demands robust process control, real-time visibility, and rigorous change management to ensure quality, compliance, and operational efficiency at every stage.  What role do you see Pharma 4.0 and digital manufacturing playing in shaping the next generation of biotech production facilities in India?  Biomanufacturers often manage multiple processes simultaneously. The challenge is maintaining consistent quality, ensuring compliance, and having complete visibility into what’s happening across the plant without creating additional operational overhead. That’s where I believe Pharma 4.0 delivers its greatest value. A connected manufacturing environment enables information to flow seamlessly across the facilities, leading to faster decisions, stronger compliance, and more reliable production outcomes.  We’ve seen this firsthand at a life sciences facility, where ABB integrated nine manufacturing blocks onto a common automation platform. Rather than operating as separate islands of information, production, utilities, environmental monitoring, and quality related data were integrated into a unified control system. This gave operators and plant managers a real-time view of site-wide operations, making it easier to identify deviations, understand the impact of process changes, and maintain traceability throughout the manufacturing lifecycle.  Why are data visibility, traceability and data integrity becoming increasingly critical for biotech manufacturers, and how can digital technologies address these requirements?  Data is no longer just a record of what happened; it is the foundation for better decisions, faster scale-up, and more consistent outcomes. Reliable, traceable, and accessible data is critical to maintaining product quality and compliance. When a process deviation occurs, for example, manufacturers need immediate visibility into every material, process step, and operating condition associated with a batch.  A unified automation platform enables this by connecting operations, capturing information in real time, reducing manual errors, and creating a trusted data foundation across the manufacturing lifecycle. In highly regulated environments, compliance with standards such as FDA 21 CFR Part 11 requires secure electronic records, electronic signatures, and time-stamped audit trails. By bringing production data, workflows, and quality processes together, manufacturers can strengthen data integrity and end-to-end traceability while remaining audit-ready. Built in cybersecurity, secure data management, reporting, and automated compliance capabilities further help create a more connected, transparent, and resilient manufacturing environment. What opportunities does automation create for biotech companies looking to transition towards larger scale or continuous production models?  Think of automation as the brain of a manufacturing operation, continuously coordinating thousands of interconnected activities across the plant. Just as the brain enables different parts of the body to work together seamlessly, automation connects processes, equipment, and data to keep production running smoothly and consistently. It helps maintain tight control over critical conditions, reducing variability and enabling faster, more reliable decisionmaking. This is especially important in continuous production, where operations must run 24×7 seamlessly without interruption. More broadly, automation allows manufacturers to scale with confidence, transfer processes more effectively, strengthen compliance, and respond more quickly to changing market demands. It is not simply a tool for operating a larger facility but the foundation for turning scientific innovation into repeatable, commercially viable production.  Why is it important for biotech manufacturers to take an integrated approach to plant infrastructure, connecting production, utilities and other critical systems?  A biomanufacturing facility functions as a connected ecosystem, where production is only one part of the equation. Supporting systems such as utilities, power infrastructure, building management, and process controls must operate seamlessly together to create the stable, controlled environment required for efficient and reliable manufacturing.  A “one plant, one system” approach brings these elements together through a common automation platform, providing a unified view of the entire ecosystem. The result is a single source of truth across the facility, improving visibility, strengthening data integrity, and creating a scalable foundation for growth. An integrated architecture also lowers maintenance costs, simplifies upgrades, and eliminates the need to train personnel on multiple automation platforms.  By standardising operations on a common platform, manufacturers can accelerate onboarding, enhance workforce flexibility, and maintain consistency across sites. Ultimately, an integrated plant is not only easier to operate but also more resilient, efficient, and better equipped to support the rapid scale-up and agility that modern biotech manufacturing demands.  swati.rana@expressindia.com  Swatirana.express@gmail.com    The post India’s biotech growth story is now a manufacturing story: G Balaji appeared first on Express Pharma.