Course Description:
Cell and gene therapy is lifesaving for specific and formerly untreatable medical conditions. Very high costs are associated with manufacturing cell and gene therapies even as demand to treat severe disease is on the rise. How can developers and manufacturers mitigate risks, drive down costs, decrease turnaround time, increase efficiency when it comes to pharmaceutical and biologics design processes? What innovations and best practices, derived from early products such as CAR-T technologies, can be leveraged to develop cell and gene therapy products that realize the potential of advanced therapeutics and save lives around the world?
1- Increasing Manufacturing Success
Current technologies suffer from low success rates due to poorly understood cell population criteria and lack of early phase characterization of apheresis material. We discuss how to reduce costs and manufacturing time for CAR-T cell therapies; AAV; LV-based gene therapies.
2- Reducing Turnaround Time
Arm-to-arm cell therapies take weeks to manufacture, but further understanding of T-cell mechanisms for activation and surface stimulation may provide manufacturing flexibility and reduced turnaround time.
3- Single-use, Automation, and Platform Technologies
Heavily manual cell therapy processes can be improved with single use systems and integration with automated platforms; AAV or LV-based gene therapies benefit from platform technologies that offer greater recovery yields.
4- High Efficiency & Low-cost Viral Vector Production
Vector production remains one of the highest costs in the CAR-T manufacturing process, but alternatives like allogenic cell therapy can result in scalable processes with higher success rates; CRISPR and electroporation gene incorporation offer cheaper alternatives to viral vectors.
Who should participate:
Drug manufacturing, pharmaceutical manufacturing, biomanufacturing, biologics organizations; Job function: process design, quality assurance (QA), quality control (QC), operations managers, quality management, pharmaceutical quality directors, MHA, MPH.
Though this course is being made available on USP’s Education site, the course content was developed by Pharmatech Associates, a USP company. USP has not independently reviewed or verified the accuracy of the course content.