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Center of Cell and Gene Therapy
«CRYOCENTER SAINT PETERSBURG»
Stem Cell Bank «POKROVSKI»
Alexander Smolyaninov,
M.D.,Ph.D.,
General Director
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company in Russia, focusing on the development and commercialization of gene and cell therapies to treat life-threatening diseases including genetic disorder, cancer and cardiovascular disease. Stem cells banking (including Human peripheral blood stem cells banking, Human umbilical cord
hematopoietic stem/progenitor cells banking, Human Bone marrow derived stem cells banking).
«CRYOCENTER SAINT PETERSBURG» is an integrated company
covering all function from laboratory to the proof clinical efficacy: discovery, production, clinical development and operations, supported by quality
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To provide effective and permanent remedies to high social impact disease by
developing innovative molecular medicine therapies to improve healthcare and quality of life.
To integrate a national multi-institution research and discovery program to
develop treatments for serious diseases through the application of stem cells and related technologies.
A core role of the Center is to attract and secure commercial partners to
advance outstanding research outcomes towards clinical trials initially, and eventually into the hands of medical practitioners for the benefit of their patients.
Complementary to these goals, the Center of Cell and Gene Therapy
«CRYOCENTER Saint Petersburg » Stem Cell Bank «POKROVSKI»
proactively works to enhance the public’s awareness and understanding of stem cell and regenerative research.
Involvement and collaboration with international stem cell groups and
networks is a vital activity that further adds value to the Center’s scientific goals.
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For relevant protocols and procedures within the Center of Cell and Gene
Therapy «CRYOCENTER Saint Petersburg » Stem Cell Bank
«POKROVSKI» has been developed to comply with cGMP requirements. In
addition to covering all stages of production, namely collection, processing, storage and release, it also addresses the following elements: equipment (purchase, use, and maintenance); materials (specifications, quarantine, and release); and quality systems (quality control, validation, and document control).
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Harvesting, Aphresis Collection
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Cell Processing Center
The Cell Processing Center is the most tangible aspect of a Center facility and it must conform to a variety of requirements to meet the demands of GMP. The total space of these laboratories occupies approximately 500 m2. Production is undertaken in four Class 10,000 (ISO5, Class 350) fully-equipped cleanrooms containing Class 100 (ISO7, Class 3.5) workstations. These rooms are designed to facilitate flexible, protocol-specific
configurations. The rooms can operate independently under positive or negative pressure and the facility meets all physical containment level 3 (PC3) international standards.
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Cryopreservation
- three workspace suitable for simultaneous processing of bio-materials
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Storage/Banking (Vapour Phase Liquid N2)
- for long-term banking, there is a vapour-phase liquid nitrogen storage facility equipped with five autofill 365-liter tanks supplied via insulated vacuum lines from a 2,000-liter supply tank.
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Support
Infrastructure
Patient recruitment Research Laboratories Clinical interpretation Statistical center10
«CRYOCENTER Saint Petersburg » Stem Cell
Bank «POKROVSKI» staffing is detailed in the
organizational chart (see below), which conforms to
cGMP requirements. Specifically, there is a production
arm that includes Center of Cell and Gene
Therapy «CRYOCENTER Saint Petersburg »
Stem Cell Bank «POKROVSKI» staff in apheresis,
cryopreservation, and the cell manipulation
laboratories. To maximize flexibility, we staff the cell
manipulation laboratories with hospital pharmacy
technicians who have additional cell manipulation
training and are employed on an ‘as needed’ basis.
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APHERESIS MANAGER
PRODUCTION MANAGER Head Scientist Clinical Cell
Manipulation
HEAD SCIENTIST Experimental Cell manipulation
QUALITY MANAGER APHERESIS NURSES DEPUTY PRODUCTION MANAGER DOCUMENTAL CONTROL OFFICERS QUALITY SYSTEMS OFFICERS SENIOR SCIENTIST -CRYOPRESERVATION FACILITY SUPERVISOR Cell Therapy Scientist
PROJECT SCIENTIST Research Protocols PROJECT SCIENTIST Clinical Protocols CLEANROOM ASSISTANTS CELL THERAPY TECHICIANS CELL THERAPY TECHICIAN Research Protocols CELL THERAPY TECHICIAN Clinical Protocols CRYOPRESERVATION SCIENTIST
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Cardiology, National Cardiology Research Center, Moscow, Russia, Vladimir N. Smirnov, M. D.,
Professor.
Institute of Clinical Immunology,
Russian Academy of Medical Sciences, Siberian Branch, Vladimir A. Kozlov, M. D., Professor
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Gynecology and Perinatology of the Russian Academy of Medical Sciences, Moscow, Russian, Evgeny V. Zharov, M. D., Professor
Center for Regenerative Medicine,
Cancer Center, Massachusetts General Hospital, Harvard Medical School, Boston, USA, David T. Scadden.
Smolensk Regional Institute of
Pathology, Smolensk, Russia, Alexander A. Dorosevich, M. D., Professor
StemCell Technologies Inc., Canada,
official distributor in Russia Chembio ltd., Irma Sakhyria
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Inc., Newton, USA, John R. Rizza Sr.
Massachusetts General Hospital,
Center for Integration of Medicine and Innovative Technology
(CIMIT), Boston, USA, Jeffrey A. Gelfand, M. D.
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Environment Sustainable Development and Healthy Environment WHO/HQ, Geneva, Switzerland, Shunichi
Yamashita, M. D., Ph. D.
Atomic Bomb Disease Institute of
Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan, Masao Tomonaga, M. D., Ph. D.
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Mesenchymal stem cell transplantation
Immunotherapy
Dendritic cells, natural killer cells, lymphocytes, activated macrophages Conditionally lethal “suicide” gene therapy
Cardiovascular disorders(Infarction, heart failure, rhythm disturbances, atherosclerosis) Bone marrow stem cell transplantation
Multipotent stem cells
Stem cell-based gene therapy — angiogenesis
Orthopedic tissue repair(Joint trauma, osteogenesis imperfecta, chondrodysplasias, osteoarthritis, non-healing fractures)
Expanded chondrocytes
Chondrocytes, biocompatible matrix Stem cell-derived chondrocytes Mesenchymal stem cells
Diabetes
Transplanted pancreatic islet cells Stem cell-derived islet cells
Neurologic disorders(Parkinson's disease, Alzheimer's disease, multiple sclerosis, spinal cord injury, stroke, amyotrophic lateral sclerosis)
Allogeneic or xenogeneic neural cells Stem cell-derived neural cells
17 K. L. Kozlov, D. A. Kirillov
Base of Cell and Gene Therapy in Cardiovascular Disorders. Moscow, 2005.
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