January 18, 2011 -- The Fraunhofer-Gesellschaft undertakes applied research of direct utility to
private and public enterprise and of wide benefit to society.
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
Fraunhofer Institute for Cell Therapy and
Telefon +49 341 35536-1000
Fax +49 341 35536-9921