From DNA To IND In As Little As 6 Months: Fast To Clinic, Designed To Scale, Backed By Experience

As the urgency to advance promising antibody therapies continues to grow, traditional development timelines are increasingly being reexamined to enable faster, more efficient progress. This webinar presents an integrated drug substance and drug product CMC solution designed to compress the journey from DNA to IND to as little as six months, offering a new level of speed for early-stage biologics programs.

Built on more than 30 years of biologics development and manufacturing experience, this approach is supported by a proven track record of successfully delivering IND-enabling CMC modules. Attendees will gain insight into the technologies and workflows that make this acceleration possible, including next-generation cell line development, platform-based upstream and downstream processes, and a streamlined, phase-appropriate CMC strategy aligned with regulatory expectations. The session will highlight how platform approaches, parallel workstreams, and digital, data-driven development strategies work together to reduce risk while maintaining product quality and scientific rigor. In addition, practical guidance will be provided for early-stage biotech companies, focusing on how to avoid common bottlenecks and how to effectively partner with a CDMO to enable rapid execution without compromising robustness or future scalability. Real-world examples will demonstrate how accelerated timelines can be achieved in practice and how this integrated approach can support efficient progression to the clinic.

By watching the presentation below, viewers will leave with a clearer understanding of key development challenges in early antibody programs, actionable strategies to mitigate risk while maintaining regulatory alignment, and insight into how integrated CMC workflows and CDMO partnerships can drive faster, more predictable paths to IND.