Walkersville, MD (USA), 15 October 2015 – Lonza, a global leader in the field of cell therapy development and manufacturing, announced today the publication of an article about the recent completion of the production of clinical-grade induced Pluripotent Stem Cells (iPSCs). The success was reported in a peer-reviewed article titled “cGMP-Manufactured Human Induced Pluripotent Stem Cells Are Available for Pre-clinical and Clinical Applications” in the scientific journal Stem Cell Reports. The article can be found in Lonza’s Knowledge Center: www.lonza.com/ipscarticle
The discovery of iPSCs and the availability of protocols for their cell-type specific differentiation provide the ground work for the development of iPSC-based cell replacement therapies. Several groups have programs underway that focus on the use of iPSC-derivatives for clinical applications. Addressing the challenges of donor-tissue sourcing, the manufacturing under cGMP-compliant conditions and the distribution of iPSC-derived product have been critical to enable and accelerate the use of iPSCs for clinical applications. Lonza recognized these challenges and in this article presented solutions to advance the field of stem cell commercial manufacturing.
Lonza’s article describes the efforts to develop a process for cGMP manufacturing of iPSC master cell banks (MCBs) and announces the availability of such banks. The article emphasizes the importance of tissue acquisition, development of a cGMP-compatible process, raw material handling and supply chain considerations, transferring the manufacturing process to clean-rooms, and testing/characterization of the clinical-grade iPSCs.
“By publishing this manuscript, Lonza is providing access to the concepts and methods for generating clinical-grade iPSCs and helping researchers in the regenerative medicine field take this revolutionary technology forward,” said Andreas Weiler, PhD., Head of Emerging Technologies, Lonza Pharma&Biotech.
“The basic protocols are provided to the community free-of-charge,” explained Thomas Fellner, PhD., Head of Commercial Development for Cell Therapy. “Together with the commercially available L7™ Culture System, we hope to enable the field to accelerate development of iPSC-based therapies.”
The clinical-grade cell line will be accessible to researchers globally for the development of iPSC-based therapies. A matched research-grade working cell bank will also be accessible for use in research and preclinical studies. A Drug Master File (DMF) for the iPSC production process, which can be referenced in regulatory filings, is owned by Lonza and has been filed with the U.S. Food and Drug Administration (FDA).