Abstract To accomplish the legal national and international requirements for the elaboration of elements for advanced therapies, the Maimonides University.

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Abstract To accomplish the legal national and international requirements for the elaboration of elements for advanced therapies, the Maimonides University of Buenos Aires, Argentina built a GMP laboratory of 400 square meters divided into three different areas, distinguished one from other through their level of Bio- safety: 1.Level 2 (BIO 2) dedicated to quality control and quality assurance test as well as animal studies. 2.Level 3 (BIO3) dedicated to the process of non contaminated human cells to be used in cell therapy and / or tissue engineering, cell freezing and banking and Tissue Culture Media elaboration. 3.Level 4 (BIO4) is dedicated to the process of cells for gene engineering or contaminated cells for cellular therapy. The door access to each area and laboratory is controlled by personal magnetic card that allows the use of each room according to the level of authorization of each user. Bio 2 counts with a reception desk were each sample is registered, assigned to a specific process and labeled with bar code etiquette. There is a laboratory with molecular biology equipment and patch clamp testing, a second laboratory with FACS equipment and fluorescent microscopy, two laboratories with cell incubators, micromanipulator to nucleolus transfer, animal cell processes and culture. Finally is a washing area with two double doors autoclaves. The access to bio 3 is through a pressured concourse where there is necessary to change clots. There are six equal culture rooms with all the necessary equipment to do not need to go to a second room to complete a cell process, avoiding cross contamination. A seventh laboratory to frozen and storage cells as well as to prepare tissue culture media. The equipment of BIO 4 is under construction for Baker Company. Liquid wastes are decontaminated in a treatment plant. The water supplied came from an own invert osmosis plant GMP LABORATORY FOR ACADEMIC CELLULAR THERAPY; TISSUE ENGINEERING AND GENE THERAPY DEVELOPMENTS AND CLINICAL TRIALS SUPPLAY AT MAIMONIDES UNIVERSITY - ARGENTINA G A Moviglia CIITT, Universidad Maimonides, Buenos Aires, Argentina GMP Cell Process Laboratory Names of the Different Areas BSL 4 Area Walls Uncontrolled Doors Manual Controlled Doors Electronic Controlled Doors Uncontrolled BSL 2 Area BSL 3 Area Shower Chemical Pass Through Double Door Autoclave GMP Cell Process Laboratory Air Quality, Relative Pressures and Air Flow Direction BSL 4 Area Uncontrolled BSL 2 Area BSL 3 Area Shower Chemical Pass Through Double Door Autoclave Capitol Letters indicate air quality Numbers Indicate Relative Air Pressures in each area D Less than particles per f 3 C Less than particles per f 3 B Less than 100 particles per f 3 B Less than 100 particles per f 3 Air Flow Direction Laboratory Fates Lab 2-1: Molecular Biology and Microbiology.Lab 2-1: Molecular Biology and Microbiology. Lab 2-2: Animal Cell Culture.Lab 2-2: Animal Cell Culture. Lab 2-3: Flow Cytometry - Microscopy.Lab 2-3: Flow Cytometry - Microscopy. Lab 2-4: Animal Cell CultureLab 2-4: Animal Cell Culture Lab 3-1: Cell Selection and Leukocyte Treatments.Lab 3-1: Cell Selection and Leukocyte Treatments. Lab 3-2: Quarantine of non suspected contaminated cells.Lab 3-2: Quarantine of non suspected contaminated cells. Lab 3-3: Somatic Cell Culture and Differentiation.Lab 3-3: Somatic Cell Culture and Differentiation. Lab 3-4: Tissue Engineering.Lab 3-4: Tissue Engineering. Lab 3-5: Tumor Cell Culture And Tumor Cell Vaccine Elab.Lab 3-5: Tumor Cell Culture And Tumor Cell Vaccine Elab. Lab 3-6: Cancer Patient Leukocyte Process.Lab 3-6: Cancer Patient Leukocyte Process. Lab 3-7: Tissue Culture Media Elaboration and Storage. Cell Freezing and StorageLab 3-7: Tissue Culture Media Elaboration and Storage. Cell Freezing and Storage Lab 4-1: Quarantine of Suspected Contaminated CellsLab 4-1: Quarantine of Suspected Contaminated Cells Lab 4-2: Genetic EngineeringLab 4-2: Genetic Engineering Lab 4-3: Cell Process of Contaminated or Exposed to Pathogenic Agents Cells.Lab 4-3: Cell Process of Contaminated or Exposed to Pathogenic Agents Cells. Large Equipment Biosafety 1 Hood Incubator and Under - bench 4°C Refrigerator Bench 4°C Refrigerator -150º C Freezer -20º C Freezer Laboratory Glassware Wash Machine Biosafety 2ª Hood Biosafety 3 Hood -86º C Freezer Clinimac and Under - bench 4°C Refrigerator Lab 2-3: Flow Cytometry - Microscopy. Washing and Sterilization Area Two Double Door Autoclave Concourse of Service 3 Lab 3-2: Quarantine of non suspected contaminated cells. Lab 3-7: Tissue Culture Media Elaboration and Storage. Cell Freezing and Storage Lab 3-1: Cell Selection and Leukocyte Treatments Lab 3-3: Somatic Cell Culture and Differentiation #155