Friday, August 14, 2026 – Conference Day 2Friday, 14 August 2026

Reserved for Partners

• Challenges: High cost of goods limiting market access. o Competing with global biosimilar manufacturers.
• Discussion Points: o Role of technology in reducing production costs. o Strategies for scaling biosimilar manufacturing in India.

India’s biopharmaceutical sector is undergoing a transformative shift driven by the need for higher productivity, cost efficiency, and accelerated development timelines. Recent advances in bioprocessing equipment and enabling technologies are redefining process design, scale, and control bioproduction systems. Innovations such as intensified upstream processing, next‑generation single-use systems, continuous manufacturing platforms, advanced PAT-enabled automation, and AI-driven process modeling are significantly improving process robustness and reducing time-to-market. Concurrently, localized equipment manufacturing, modular facility designs, and end-to-end digital integration are lowering capital expenditure and enabling rapid capacity expansion tailored to India’s fast-growing biologics, vaccines, and biosimilars markets. Collectively, these advancements are positioning India to compete globally by enabling high-quality, compliant, and economically viable bioprocessing. This talk covers a concise overview of the technological and equipment breakthroughs reshaping and highlights their impact on innovation, operational agility, and long-term industry sustainability

• · An increasing number of molecules is coming through the pipeline because of AI for drug discovery and clinical trials, requiring process development and operations to become more cost and time effective.
• With the rise of AI, the expectation is for digital tools to streamline process development while delivering robust, high-performance processes.
• Examples of data management and process modeling applications will be shown, which indicate that wet-lab experimentation can be reduced, when used alongside the traditional way of working.
• Beyond process modeling, digital twins combined with augmented and virtual reality technologies are enabling immersive facility design reviews, operator training, and enhanced knowledge transfer, helping organizations improve efficiency and reduce operational risk.

The global demand for biotherapeutics continues to rise, placing significant pressure on manufacturing platforms to deliver higher productivity without compromising product quality or process robustness. Intensified cell culture—through modalities such as high‑seed fed‑batch, N‑1 perfusion, and continuous perfusion production—has emerged as a powerful approach to increase volumetric productivity and facility throughput. However, translating these intensified processes from development scale to manufacturing scale introduces new challenges to maintain the productivity and product quality. We successfully scaled up both the intensified fed‑batch process and the ATF‑based perfusion process from laboratory scale to manufacturing scale by applying appropriate bioreactor engineering principles and robust scale‑up strategies.

As the biopharmaceutical industry evolves, cell and gene therapies are some of the fastest growing therapeutic modalities. Access to high-quality medicine is also essential for improving public health. New standards are needed to ensure the quality, safety, and efficacy of advanced therapeutics such as adenoassociated virus (AAV) based gene therapy and Lentiviral vector (LVV) based CAR-T cell therapy. Reliable analysis of critical quality attributes (CQAs) is essential for maintaining product quality and patient safety. Properly leveraging standards can significantly improve performance by enhancing consistency and accuracy. Based on the feedback from stakeholders and United States Pharmacopeia’s (USP) expert volunteers, we have identified critical scientific challenges and developed a portfolio of best practices, compendial methods, and biological reference standards to support analytical testing. This talk will provide an update on the development and evolution of standards for AAV and LVV that focus on three key challenging areas: raw material qualification, vector characterization, and impurity quantification. These standards were designed to facilitate testing of key CQAs, including assessment of empty/full capsids, genome titer, capsid titer, integration copy number, process impurities, and raw materials. Attendees will gain insights into USP’s ongoing initiatives to support quality of biologics through standards and how USP standards can help facilitate regulatory compliance, enhance analytical precision, and accelerate adoption of best practices in manufacturing and testing.

ROUND TABLES RT 1: Scaling Flexibility: Integrating Single-Use Systems in Indian Biomanufacturing (Reducing downtime, operational risk, Technology adoption barriers and solutions, cost via disposable bioreactors, dealing with supply chain challenges, managing plastic waste and environmental concerns, feasibility of single-use systems in competitive biosimilar and biotech markets.)

RT 2: Phase-Appropriate Analytical Strategies: What to Test and When- This session outlines a phase-appropriate approach to analytical testing for biologics and biosimilars

• Functional assay optimization for speed and reliability
• Automation in bioanalytical workflows
• Comparative analysis requirements for biosimilars
• Regulatory considerations in analytical method development

RT 3: Next-Generation Modalities in India: From Biosimilars to AAV, mRNA, Multispecifics, Fusion Proteins, ADCs and Cell Therapies (Understand India’s current readiness for novel modality manufacturing, Learn what analytical and CMC challenges must be solved first, lessons from US / EU regulatory pathways, and the unique infrastructure and policy requirements for building sustainable novel product capability, how to scale up these complex therapies, Process Innovation vs. Product Innovation)

RT 4: CDMOs and External Manufacturing Capabilities (End-to-End CDMO Services: Current capabilities and market gaps, What's your biggest manufacturing bottleneck?, expansion of Indian CDMOs into ADCs, peptides, mAbs, how to increase capability maturity?)

RT 5: Upstream Scale Up Challenges (Challenges in scaling up from lab-scale to commercial-scale bioreactors, Addressing variability in cell culture performance during scale-up, Strategies for improving yield and productivity in upstream processes, Adoption of single-use bioreactors and their impact on scalability, Role of automation, AI, and data analytics in upstream process control, Emerging technologies for continuous bioprocessing in India, Navigating regulatory requirements for scale-up in India and global markets, Ensuring product quality and consistency during scale-up, Addressing challenges in meeting cGMP standards, Balancing cost-effectiveness with innovation in upstream processes, Strategies for reducing operational costs while maintaining quality.)