1. Cyto-Care… specialized in cell collection.

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. Cyto-Care: impressions

10. 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

11. 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

12. 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

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

14. 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

15. 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

16. 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

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