Walkersville, MD (USA), 10 October 2012 – The National Institutes of Health Center for Regenerative Medicine (NIH CRM) has awarded Lonza Walkersville, Inc. a contract to generate induced pluripotent stem cells (iPSCs) under current Good Manufacturing Practices (cGMP). The production of clinical grade iPSCs is considered a critical component to realizing the therapeutic potential of pluripotent stem cells. The contract also includes manufacturing of clinical grade iPSC-derived cell types.
In 2007, Dr. Shinya Yamanaka and colleagues at Kyoto University became the first to successfully convert adult human cells to an embryonic stem cell-like state. In 2012, Yamanaka was awarded a Nobel Prize for this work. One defining characteristic of these induced pluripotent stem cells is their ability to become any cell type in the body. Therefore, iPSC technology can be used to develop cell transplantation therapies for the treatment of degenerative diseases such as diabetes, Parkinson’s Disease and a number of cardiovascular diseases. Lonza is a global licensee of the technologies invented by Dr. Yamanaka.
“As the world leading cell therapy contract manufacturer, Lonza is committed to the field of regenerative medicine. Our goal is to help cell therapy developers navigate the complexities of process optimization and cGMP-compliant manufacturing for clinical trials and beyond,” said Lukas Utiger, President, Lonza Walkersville. “Being awarded this contract further validates Lonza’s position as the partner of choice for moving iPSC technology into the clinic.” ^
The contract awarded to Lonza is deemed an Indefinite Delivery/Indefinite Quantity (IDIQ) award which is a type of United States Government contract that provides an indefinite quantity of services for a fixed amount time. For IDIQs, although nothing is guaranteed, minimum and maximum quantity limits are specified in the basic contract as either number of units (for supplies) or as dollar values (for services). The Lonza contract is a five year agreement with a value of approximately $9.5 million dollars.
Further information on Lonza’s pluripotent stem cell technology development programs and service offerings can be found at www.lonza.com/pluripotent.