Manufacturing license for separation of stem cells from cord blood
Following a successful inspection by the Landesdirektion Leipzig, InnovaStem GmbH has gained the manufacturing license for separation of stem cells from cord blood according to § 13 German Drug Law (AMG), effective from 14th of December 2010.
InnovaStem’s manufacturing process is based on the separation of stem cells out of cord blood. After concentration of the mononuclear cell fraction, the cells are mixed with a cryoprotectant and transferred to an automatic cryopreservation system. The cell biological quality is revealed by analyzing the number of viable leukocytes, the number of viable stem cells as well as the cell viability and by determining the product’s sterility. These stem cells could be used for both autologous and intra-family application.
InnovaStem GmbH has the opportunity to draw on a well established high quality GMP-infrastructure and the scientific know how of the Fraunhofer IZI. In addition, InnovaStem GmbH and Fraunhofer IZI are currently establishing GMP-compliant manufacturing processes for isolation of stem cells out of other perinatal tissues, such as placenta and cord tissue (Wharton’s Jelly), which represent an important source of multipotent progenitor cells.
About InnovaStem GmbH
InnovaStem GmbH is a stem cell bank focusing on preparation and storage of adult stem cells derived from perinatal tissues such as cord blood, cord tissue (Wharton’s Jelly) and placenta tissue, respectively. InnovaStem GmbH was founded in August 2009 in Leipzig as German subsidiary of its Italian parent company Innovative Medical Solutions S.r.l (IMS), now rebranded as InnovaStem S.R.L. Whereas IMS has gained experiences in collecting cord blood in Italy as a private organization since 2004, its intention was to establish a directly associated GMP-facility for processing and storage of stem cells in Germany. During the last year, with the help of Fraunhofer IZI, InnovaStem GmbH has set up a complex quality management system in accordance with EU GMP Guidelines and has established the manufacturing processes for separation and cryopreservation of stem cells as well as the analytical methods for control of the cell biological qualities.