• June 3-6, 2024
  • San Diego Convention Center, California



Development of Cell Therapy Products through Global CDMOs

Tuesday, June 04, 2024
BioProcess Theater Session
The majority of innovative ideas and disruptive technologies are nucleated at academic and educational institutions. However, these organizations have limited budget and lack the process development and manufacturing infrastructure, particularly if their advanced products belong to different technological platforms. This gap can be closed by contract development and manufacturing organizations (CDMOs), which remain crucial to new drug process development, manufacturing, and commercialization. The goal of this presentation is to provide the framework for the development of modern biologics through global CDMOs. A case study on chimeric antigen receptor T-cells (CAR-T) that is currently undergoing clinical trials in the immuno-oncology field will be presented. This program required the involvement of five different CDMOs located in different parts of the world due to the unique nature of these drug products. The CDMO selection process includes business documentation, GMP/Quality due diligence process, CDMO structure analysis, communication, technical expertise, as well as establishing a timeline and a budget. This presentation will cover the key benchmarks in analytical and process development to ensure a successful manufacturing outcome.
Vadim Klyushnichenko
VP Bio/Pharmaceutical Development & Quality
Calibr-Skaggs Institute for Innovative Medicines
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