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Feature|Videos|May 14, 2026

Expanding CDMO Capabilities in Drug Manufacturing

Key Takeaways

  • Identify current industry benchmarks and compare them to emerging CMC timelines for both early-stage and late-stage biologics development.
  • Understand four platform technologies for WuXi Biologics that are advancing biologics development.
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CDMOs are changing tactics in order to meet faster timelines, manage multiple manufacturing platforms, and navigate the industry's shift toward complex biologics.

Sponsored by WuXi Biologics

The biologics industry faces persistent challenges with lengthy CMC timelines; the industry average for DNA-to-IND sits at 14 months and late-stage CMC development often stretches to 36 months, creating significant bottlenecks for drug developers. The pipeline is also growing more complex, with multi-specifics and antibody-drug conjugates now outpacing monoclonal antibodies in new project volume, demanding more sophisticated development and manufacturing capabilities. To address these challenges, Nuno Fontes, SVP, Head of Global CMC at WuXi Biologics, describes how they have developed accelerated CMC timelines—as short as six months for DNA-to-IND and 15 months for IND-to-BLA. Alongside timeline, they have four platform technologies spanning single-site cell line development, process intensification, real-time process analytics, and high-concentration subcutaneous formulation. These capabilities combined with an emphasis on early CMC planning, aim to give drug developers a faster, more predictable path from early-stage development through commercialization.

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