Friday, August 14, 2026 – Conference Day 1Friday, 14 August 2026

Reserved for Partners

• Challenges: o 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.

• Advances in single-use bioreactors and their impact on cost reduction.
• Automation technologies for seamless process integration.
• Case studies on successful implementation of innovative equipment in Indian facilities.

Reserved for Partners

• Benefits of process intensification for cost reduction and productivity.
• Exploring continuous chromatography and perfusion systems.
• Case studies on successful implementation of continuous manufacturing technologies.

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.

Reserved for Partners

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: Accelerating Biotech Innovation as a Start Up: Successes and Lessons Learned (How can start ups accelerate workflows, reduce costs, and innovate)