FDA Compliant Stem Cell Manufacturing Process Made Available Free of Charge

In recent years, human-induced pluripotent stem cell (“IPS cell”) research has emerged as a treatment modality that potentially avoids the ethical objections connected with embryonic stem cells.

First produced in 2007, IPS cells are differentiated so that they serve a specific function, like dopamine production, before being implanted. Undifferentiated cells can form tumors called teratomas and therefore, differentiating cells is key to enhancing safety.

Biotech company, Lonza, has published a paper detailing the company’s stem cell manufacturing process and announced the availability of its IPS cell banks. In the paper, the company states: “To our knowledge, no fully cGMP-compliant cell line has been generated where the entire manufacturing process, from tissue sourcing to cell expansion and banking processes as well as documentation, raw materials, staff training, cell therapy facility, and quality control (QC) testing, was validated.”

The design will be compliant with FDA’s Good Manufacturing Practices and the basic process is available without charge, though the detailed version (the one that produced Lonza’s cell banks) is still proprietary.

Source: http://www.sandiegouniontribune.com/news/2015/sep/24/induced-pluripotent-stem-cell-lonza-manufacturing/

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