An optimal path to IND for your mAb
Our DNA to IND program is designed for teams seeking faster progression to IND while maintaining product quality, development rigor and regulatory readiness. Speed is enabled through proven platform approaches, integrated execution and targeted technologies that compress time and support faster milestones, without reducing quality standards or introducing unnecessary risk.
The program is designed to support different development strategies. Depending on starting material and program requirements, the pathway supports either a 6*‑ or 8‑month† DNA‑to‑IND timeline, while maintaining alignment with IND‑enabling requirements.
Alternatively, you may choose to pause or progress at key milestones, aligning development activities with program readiness, data review, portfolio decisions or funding timelines.
†Based on the use of clonal material. From DNA transfection to delivery of IND-enabling CMC modules. Subject to terms and conditions.
*Based on the use of pool material. From DNA transfection to delivery of IND-enabling CMC modules. Typical timelines. Subject to agreement with regulatory authorities.