An optimal path to IND for your bispecific
Our integrated DNA-to-IND program is designed for teams seeking faster progression to IND while maintaining product quality, development rigor and regulatory readiness. For standard- and high-concentration bispecific antibodies, speed is enabled through a combination of proven platform knowledge, integrated execution and molecule-specific development strategies that help accelerate progress while maintaining confidence in critical development decisions.
The program is designed to support different development strategies. Depending on program requirements and development priorities, the pathway can support IND submission in as little as 6 months* or 8 months† while maintaining alignment with IND-enabling requirements.
Every molecule's journey is unique. While these accelerated pathways are designed to help programs reach IND faster, development activities can also be aligned around key milestones, enabling teams to progress at a pace that reflects program readiness, data review, portfolio priorities and funding timelines.
*From DNA transfection to delivery of IND-enabling CMC modules. Subject to terms and conditions.
DNA to IND pathways for your bispecific, selected around your program priorities
†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.
