Cyto-Care… specialized in cell collection. www.cyto-care.eu

Cellular therapy in oncology Immunosurveillance theory (immuno-editing) Personalized therapy: Activation of the patient's own immune system to fight against cancer Leukocytes or leukocyte subtypes as starting material for cellular therapy strategies Complex interaction between clinical medicine, cell collection, and drug production Cell collection as a critical step towards drug development and drug production www.cyto-care.eu

Cyto-Care Founded in 2006 and re-named to Cyto-Care (2010) Located in a central district of Vienna Currently 6 employees Two Medical Doctors specialized in Transfusion Medicine and Immunohematology Four certified nurses specialized as apheresis operators www.cyto-care.eu

Cyto-Care: goals and vision Collection of high quality leukapheresis products and other sophisticated blood products for clinical studies and research proposes in accordance to highest international quality standards and manufacturing regulations Filling the gap between patient-orientated clinical medicine and process-orientated pharmaceutical organizations www.cyto-care.eu

Cyto-Care: role in the treatment process Decision for treatment: patient/ oncologist Cyto-Care Cell collection (leukapheresis) Manufacturing of the ind. cellular product Clinical treatment: patient/ oncologist www.cyto-care.eu

Cyto-Care: the medical team Christoph Buchta, MD, MBA certified in General Medicine, Transfusion Medicine and Immunohematology Certified expert in GMP and QM more then 10 years clinical experience in leukapheresis Markus Dettke, MD Assoc. Professor, Med. University of Vienna certified in General Medicine, Transfusion Medicine and Immunohematology more then 15 years clinical experience in leukapheresis www.cyto-care.eu

Cyto-Care: structure and responsibilities C. Buchta and M. Dettke Physicians Consultant specialists for GMP surveillance Hygiene surveillance Head nurse Associated nurses and operators Responsibilities are regulated in job descriptions www.cyto-care.eu

Cyto-Care: equipment Currently two simultaneous leukapheresis procedures possible (6 patients/ day) Optional up to 6 simultaneous cell collections possible (up to 18 patients/ day) Two apheresis devices; one elutration device www.cyto-care.eu

Cyto-Care: impressions www.cyto-care.eu

Cyto-Care: basic hematology lab Determination of blood count and differential blood count immediately before start of the leukapheresis Allows the optimal adjustment of the apheresis device to guarantee maximal collection efficacy www.cyto-care.eu

Cyto-Care: labeling of cell products All cell products are numbered consecutively and labeled with a bar code according to ISBT 128; our facility identification code is A0152 Additional bar code labeling is possible www.cyto-care.eu

Cyto-Care: process and quality control management Detailed process descriptions SOPs for each production step Emergency management Detailed hygiene and GMP management with external control Continuous training of all employees Re-certifications of the equipment Strict selection of our suppliers and external service providers; routine audits www.cyto-care.eu

Cyto-Care: products and product specifications Quantity (range) Purity (median) white blood cells 3x109-1x1010 > 85% MNC* enriched monocytes 1x109-5x109 > 80% purity** enriched T-cells 3x109-6x109 > 85% purity** * MNC=mononuclear cells; results of 188 leukapheresis procedures ** as determined by FACS www.cyto-care.eu

Cyto-Care: product release Each individual product is delivered with complete documentation Actual results of the microbiological screening tests (HIV, Hepatitis-B, -C, Lues) Product specification Hematological key data Safety sheet www.cyto-care.eu

Cyto-Care: transportation, international delivery Validated transport boxes Temperature controlled transportation Cooperation with international transport services Experience in the delivery of cell products within the EU and from the EU to Asia www.cyto-care.eu

Cyto-Care: our current engagement Biotech industry Participation in an international phase I/II clinical trail Research organizations Production and delivery of leukocyte subtypes from healthy donors for research proposes Cooperation with practical oncologists www.cyto-care.eu

Contact: www.cyto-care.eu office@cyto-care.eu