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Webinar

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

FAQs

Aragen completed cell line development, process development, and first Phase 2b/3 cGMP batches at 2KL scale for Daretabart in nine months — including titer improvement during scale-up and right-first-time GMP execution. Timelines vary by molecule complexity, but this represents a documented baseline for a standard IgG mAb on an FDA Fast Track program.

It compresses every manufacturing milestone. Clinical supply must arrive sooner, CMC documentation must be audit-ready earlier, and the CDMO must be equipped to support pre-BLA FDA interactions. Daretabart holds FDA Fast Track Designation and is progressing toward BLA submission, with Aragen's Bengaluru facility scaling to meet both clinical and commercial supply needs.

The facility houses multiple single-use 2KL bioreactors configured for standard and intensified fed-batch production, delivering one batch every four to five days at full utilisation — approximately 60–70 batches annually. It supports both scale-up and scale-out strategies for clinical and commercial programmes.

CHOMax™ is Aragen's proprietary cell line development platform that delivers an integrated DNA-to-IND pathway in approximately nine months for standard IgG mAbs. Refined across 200+ CHO programmes, it covers cell line development, process development, analytics, and GMP manufacturing under a single quality system aligned to FDA, EMA, and PMDA expectations. Cell line ownership is fully transferred to the sponsor — royalty-free, with no back-end fees.

It separates R&D and cell line development from GMP-scale manufacturing across two sites under one quality system. Aragen's model places innovation in California and GMP execution in India — delivering industry-competitive COGS without fragmenting programme ownership or quality accountability across multiple vendors.
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