iPSCs & Single Cell Isolation – Considerations of Clinical Manufacturing Workflow

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 fulfilling GMP regulations.

In this webinar, we will explore key considerations for the early stage of clinical 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 strict cell therapy, 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

• Recognize 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