Go From DNA to IND and Phase I Trials in Just 8 Months With Integrated AI/ML-Driven mAb Manufacturing

As monoclonal antibody (mAb) programs approach IND, delays often stem from fragmented development, tech transfer complexity, and limited process efficiency.

In this webinar, Thermo Fisher Scientific presents a reengineered Path to IND for biologics platform that combines advanced platform science with integrated U.S.-based manufacturing to accelerate timelines and reduce risk.

Join our Head of Technical and Scientific Affairs to explore:

• Expanded mAb manufacturing capacity: Future drug substance and product capacity in Plainville, MA to ease constraints and increase availability at sites like Groningen (NL) and Lengnau (CH).
• Advanced CHO-K1 platform with AI/ML: High-performing CHO-K1 cell line and process intensification achieving up to 11 g/L,* and enhanced by AI/ML-driven vector design and clone optimization to boost expression, stability, and speed.
• Accelerated path to IND: End-to-end biologics platform delivering IND-ready material in as little as 8 months with titer levels of up to 8 g/L.*
• Integrated process characterization and validation: Risk-based approach to PC, PV, and tech transfer to strengthen process robustness and help to accelerate PPQ readiness.
• Risk-mitigated development approach: Combines QbD, stage-gate governance, and qualified scale-down models to help to reduce variability and enable more predictable scale-up.
• Flexible scale model: Single-use bioreactor strategy (500–5,000 L) across a global network to streamline tech transfer from development through commercial manufacturing.

Discover how integrating advanced cell line engineering, high-efficiency processes, and a unified U.S. manufacturing strategy can help bring your mAb therapy to IND faster—with greater control and confidence.