Proof or probability? Latest technology for assurance of clonality in cell therapy manufacturing
For cell therapy manufacturing, an important aspect of an investigational new drug (IND) application is demonstrating that the generated cell line is clonally derived while demonstrating GMP compliance. In this webinar, we will explore key considerations for the early stage of clinical GMP manufacturing including single cell deposition methods, the importance of monoclonality assurance, consistency in the workflow, and the reduction of project timelines.
Choosing the right technology, tailored to comply with GMP regulations, will have a huge impact not only on the automation of the single cell cloning, but also on reducing hands-on time. This provides the audit trail and documentation needed for IND submission and compresses the manufacturing timelines from months to days.
Key learning objectives
- Understand the key considerations for clinical manufacturing under GMP regulations
- Understand the importance of monoclonality assurance for IND submission
- Learn about the new GMP-compliant technology for improved single cell deposition
- Discover the best approach to track clones during their journey through the manufacturing process
Who should attend?
- Biotech, large pharma, start-ups or CDMOs and CROs carrying out cell therapy, regenerative medicine and artificial meat production using:
- Induced pluripotent stem cells (iPSCs)
- Mesenchymal stem cells (MSC)
- Embryonic stem cells (ESM)
- CAR-T cells
- Academics working in cell line development and iPSCs and stem cells
Certificate of attendance
All webinar participants can request a certificate of attendance, including a learning outcomes summary, for continuing education purposes.
Speakers
