Miltenyi-Hanson Wade Webinar
Critical Pathfinding: How CDMO Partnership can Accelerate Clinical Results in Cell Therapy
The latest wave of cellular therapies is delivering an increasingly effective impact on many challenging, unmet medical needs. The realization of these long-promised novel therapeutics has spurred incredible competition to get new treatments into the clinic as quickly as possible, while generating high-quality products that are safe and efficacious.
The challenges of manufacturing novel, highly complex, living medicines are only now becoming apparent as the field has progressed in recent years. The general scarcity of such therapies proceeding to a successful IND means that experienced guidance for new developers is difficult to find and expensive to attain.
Accessing in-house expertise for early-phase clinical companies is typically infeasible, given the breadth of scientific disciplines involved in such therapies, especially when complicated by a dynamic regulatory environment. Increasingly, cell therapy developers are finding that early partnership with the right contract development and manufacturing organization (CDMO) provides access not only to the requisite GMP technical infrastructure, but also leverages the CDMO’s prior experience, qualified supply chains, and regulatory knowledge, all of which can lead to substantial cost savings and reduced time to clinic readiness.
Ian Gaudet, PhD
Senior Director, Process Sciences
Ken Chrobak, PhD
Vice President of Product Development
Xiaobin Victor Lu, PhD
Senior Vice President, Head of Regulatory Affairs
Innovative Cellular Therapeutics