Accelerated mAb Development Program

Accelerating progress from cell line development to the production of GMP drug substance for Phase 1 and Phase 2 clinical trials is essential for success. At the same time, the need to align activities with funding milestones or adhere to a stepwise investment strategy imposes cost constraints.

MilliporeSigma's accelerated mAb development program shortens development timelines for IgG1 and IgG4 monoclonal antibodies to 9 months using an established process that is phase-appropriate and cost-effective, reducing the time and cost of small-scale downstream operations by 50%. The program embodies our 35+ years of experience in monoclonal antibody (mAb) development and process knowledge, innovation, highest quality standards and risk mitigation, along with deep expertise in CMC and regulatory requirements.

MilliporeSigma can help you reduce the time and cost to clinic with confidence and build on a scalable, purpose-built process that delivers success all the way through Phase 2 and meets regulatory requirements for IND filing.