An optimal path to IND for your Fc-fusion protein
Our 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 Fc-fusion proteins, speed is enabled through a combination of proven platform approaches, integrated execution and molecule-specific development strategies that support expression, purification, formulation and analytical development while maintaining confidence in critical development decisions. Backed by deep expertise across biotherapeutic protein formats, we help teams navigate molecule-specific development considerations while maintaining momentum toward IND.
The program is designed to support different development strategies. Depending on starting material and program priorities, standard- and high-concentration Fc-fusion proteins can progress to IND in as little as 6 months* or 8 months† while maintaining alignment with IND-enabling requirements.
Every molecule's journey is unique. Development activities can also be aligned around key milestones and decision points, enabling teams to progress at a pace that reflects program readiness, data review, portfolio priorities and funding timelines.
*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. †Based on the use of clonal material. From DNA transfection to delivery of IND-enabling CMC modules. Subject to terms and conditions.
DNA to IND pathways for your Fc-fusion protein, 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.
