Blastomere Technology Agreement with Roslin Institute, Advanced Cell Technology (ACTC.OB)
- They will work together to establish a bank of Good Manufacturing Practice (GMP)-grade human embryonic stem cell (hESC) lines using ACT’s proprietary “single-blastomere” technique for deriving embryonic stem cells without damage to the embryo.
The collaboration contemplates that the hESC lines will be created and stored using protocols that meet the regulatory standards of the European Medicines Agency (EMA) and US Food and Drug Administration (FDA).
- Roslin Cells will be responsible for maintaining the banked hESC lines, which will be made available for both research and commercial purposes;
- By utilizing GMP and careful characterization and documentation of the resulting hESC lines, it is intended that the banked hESC lines will be suitable to move readily from laboratory settings into clinic programs, thereby speeding translation research into human treatments.
Predictability in price and commercialization terms is a key feature of the goals of the collaboration.
- Roslin Cells will promote access to the hESC lines from the bank as research reagents to both academic and commercial entities. In addition, ACT and Roslin Cells will publish a commercialization license so that third parties will have a reasonable and predictable path to commercialization of products using the same hESC lines that they may use in animal model studies for preclinical data.
Commercialization licenses will also provide access to the cell lines biologics master file in order to establish regulatory compliance.
- Proceeds from commercialization licenses, including milestone and royalty payments, will be shared between ACT and Roslin Cells.