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On-Demand webinar - Accelerating FDA Fast-Track Monoclonal Antibodies through integrated strategy

In this on-demand webinar, Indrani Sarkar, Associate Vice President, Assay Development & Screening at Aragen Life Sciences, explores the biological and technical considerations critical to successful GPCR-targeted drug discovery. The session highlights how a deeper understanding of receptor biology can enable the design of robust, predictive, and fit-for-purpose screening assays.

This webinar presents a detailed, data-backed account of how that outcome was made possible — and what it means for bio-techs and pharma companies with complex biologics programmes that cannot afford manufacturing delays.

Watch now to hear directly from the Aragen biologics team on the specific decisions, process design choices, and manufacturing strategies that enabled this timeline

Key Takeaways:
  • Live Case Study: Daretabart (Renaissance Pharma)

  • Obtaining First time right technology transfer

  • Integrated strategy that aligns process development, quality systems, technology transfer, validation, digital tools, and commercial operations from the outset.

  • Intensified Fed-Batch Manufacturing at Scale

  • Achieving Industry-Competitive COGS Without Compromising Quality

  • CMC and Regulatory Strategy for FDA Fast Track Programmes

Speaker
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Indraneel Sanyal
Associate Vice President, Process Development, Aragen

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Gokul Ram
Associate Director, Quality Control, Aragen Life Sciences

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Prithwish Dey
GM, Process Development & MSAT

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Abhishek Bhatt
Deputy Manager – MSAT