cGMP Compliant Primary Isolation, Expansion and Editing of a Novel Cell Therapy for an Oncology Indication
For this Case Study, the Excellos team demonstrates how a new cell therapy manufacturing methodology was tech transferred to Excellos manufacturing teams in a relatively short timeline as part of initiation of Phase I and Phase II clinical trials with the product.
- 1. Ability to develop and execute a complex cell isolation method from primary umbilical cord tissues.
- 2. Successful tech transfer of a lentiviral transduction procedure for the cell therapy.
- 3. Successful process development of a scale up procedure from tissue culture stacks to a commercial bioreactor system.