InnovaStem GmbH Release: Manufacturing License for Separation of Stem Cells from Cord Blood
Published: Jan 18, 2011
The Fraunhofer Institute for Cell Therapy and Immunology IZI is member of the Fraunhofer Group for Life Sciences. Its objective being to find solutions to specific problems at the interfaces between medicine, life sciences and engineering for partners active in medicine-related industries and businesses. The Institute’s core competencies are to be found in regenerative medicine, or more precisely in cell-therapeutic methods of regenerating non-functioning tissue and organs through to the biological substitution with tissue cultivated in vitro (tissue engineering). In order for the living organism to accept the tissues without any difficulty, it is necessary to study cellular and immuno- logical defense and control mechanisms and take these into account during process and product development. These core competencies entail a multiplicity of tasks to be solved by new products and processes. The Institute works especially closely with hospital institutions, performing quality tests and clinical studies on their behalf. Additionally it also provides assistance in obtaining manufacturing licenses and certifications.
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 organi- zation since 2004, its intention was to establish a directly associated GMP-facility for processing and storage of stem cells in Germany. Dur- ing 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 analyti- cal methods for control of the cell biological qualities.
Leipzig, January 18th, 2011 Page 2Following a successful inspection by the Landesdirek- tion Leipzig, InnovaStem GmbH has gained the manu- facturing 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.
Dr. Gerno Schmiedeknecht Phone +49 341 35536 9705 Fax +49 341 35536 9921 email@example.com
Fraunhofer Institute for Cell Therapy and Immunology IZI Perlickstraße 1 04103 Leipzig Telefon +49 341 35536-1000 Fax +49 341 35536-9921 www.izi.fraunhofer.de