Case Study: Cell Therapy Flex Platform

When speed to clinic is critical, drug developers face pressure to generate clinical data quickly to meet funding milestones and advance toward IND approval. With our 20 years of experience as a CDMO, we support clients at all stages, whether they come to us with a ready-to-transfer process or need help defining one. For an autologous CAR-T therapy client on an accelerated timeline, we began by designing a seven-day process to align with their IND and clinical trial goals while ensuring strong data and cell viability.

In this case study you will learn:

• How to develop a process tailored for an accelerated timeline for an autologous CAR-T client preparing for clinical trials
• How to support speed to clinic through a seamless workflow encompassing gene-modified cell therapy development, testing, tech transfer, and GMP preparation
• How to achieve IND approval with data that clearly defines dosing cell requirements
• How one organization can consolidate the supply chain and manage the project from vein to vein