Development of feeder-free PSC culture system enabling translational & clinical research
January 27-31, 2019
Pluripotent stem cell (PSC) culture using the xeno-free Essential 8™ Medium/truncated recombinant human Vitronectin system has been shown to support normal PSC properties and provide a large pool of cells for disease modeling and drug development. As research moves from translational to clinical research, general regulatory guidance from the US Food and Drug Administration (FDA) indicates that, cGMP manufactured, or clinical grade reagents should be used whenever available as ancillary reagents to minimize downstream risk to patients. Thus, we sought to identify regulatory compliant, animal-originfree alternatives for growth factors contained within the Essential 8™ Medium and incorporate ISO13485 manufacturing for the recombinantly expressed, truncated human Vitronectin (rhVTN-N), producing a qualified ancillary system for PSC expansion. Here we present data to support a seamless transition from the xeno-free Essential 8™ Medium system to the Cell Therapy Systems (CTS™) animal-origin free system. Compatibility is shown with existing cGMPmanufactured passaging reagents: Versene Solution for clumped cell passaging and CTS™ TrypLE™ Select combined with RevitaCell™ Supplement for single cell passaging. Upon expansion, PSCs are shown to maintain normal PSC properties, including morphology, pluripotency, karyotype, and trilineage differentiation potential. Together this system provides a consistent, feeder-free PSC culture medium for translational and clinical research.
Chad MacArthur, "Development of feeder-free PSC culture system enabling translational & clinical research" in "Advancing Manufacture of Cell and Gene Therapies VI", Dolores Baksh, GE Healthcare, USA Rod Rietze, Novartis, USA Ivan Wall, Aston University, United Kingdom Eds, ECI Symposium Series, (2019). http://dc.engconfintl.org/cell_gene_therapies_vi/28