Cord Blood, Stem & Cellular Therapies

du Moulin, G. (2004). Points to Consider in the Validation of an Automated Sterility Testing System. AABB Annual Meeting. Session 129-S: Release Testing for Cell Therapy Products.

Eichler, H., Schaible, T. et al. (2000). Cord Blood as a Source of Autologous RBC’s for Transfusion to Preterm Infants. Transfusion, 40, pp. 1111–1117.

Epstein, E., Goddard, C.M. (2005). Umbilical Cord Blood Bacteriologic Testing: Validation and Cost Effectiveness of the BacT/ALERT System. Poster #147. ISCT 2005 Annual Meeting, Vancouver.

Hami, L, Chana, H., Yuan, V., Craig, S. (2003). Comparison of a Static Process and a Bioreactor-based Process for the GMP Manufacture of Autologous Xcellerated T Cells for Clinical Trials. BioProcessing Journal, Vol. 2: 1-10.

Hickerson, D., Reese, M., Kurtzberg, J. (2005). Development and Validation of a Protocol for Sterile Sorting of Hematopoietic Stem and Progenitor Cells Based on Aldehyde Dehydrogenase (ALDH) Activity Using a Modified FACSAria Cell Sorter. Poster # 45. ISCT 2005 Annual Meeting, Vancouver.

Honohan, A., Olthuis, H., Bernards, A.T., van Beckhoven, J.M., & Brand, A. (2002). Microbial Contamination of Cord Blood Stem Cells. Vox Sanguinis, 82, pp. 28-32.

Honohan, A., Olthuis, H., Bernards, A.T., van Beckhoven, J.M., & Brand, A. (1999). Effective Sterility Testing of Umbilical Cord Blood Progenitor Cells (UCBPC) Units. AABB Poster S229-P.

Honohan, A., Olthuis, H., Bernards, A.T., van Beckhoven, J.M., & Brand, A. (1999). What Does the Term ‘Sterile’ Imply in Relation to Umbilical Cord Blood Progenitor Cell (UCBPC) Units? AABB Poster S232-P.

Jeffrey, S.R., Proffitt, A.M. et al. (2005). Comparison of the BacT/ALERT Microbial Detection System to the Standard Two-Tube, Two-Temperature USP Sterility Test Method. Poster #150, ISCT 2005 Annual Meeting, Vancouver.

Khuu, H.M., Patel, N., Carter, C.S., Murray, P.R., & Read, E.J. (2006). Sterility testing of cell therapy products: parallel comparison of automated methods with a CFR-compliant method. Transfusion. Vol.46. pp. 2017-2082.

Khuu, H.M. (2004). Parallel Study of Sterility Test Methods for Cell Therapy Products: BacT/ALERT vs. a CFR-Compliant Method. ISCT Poster #205.

Khuu, H.M. (2004). Comparison of Automated Culture Systems with a CFR/USP-Compliant Method for Sterility Testing of Cell Therapy Products. Cytotherapy. Vol.6, No.3. pp. 183-195.

Khuu, H.M. (2003). Comparison of Automated Culture Systems With A CFR/USP-Compliant Method for Detection of Microbial Growth in Cell Therapy Products. ISCT Poster #139.

Kielpinski, G., Prinzi, S., Duguid, J., & du Mouin, G. (2005). Roadmap to approval: use of an automated sterility test method as a lot release test for Carticel®, autologous cultured chondrocytes. Cytotherapy. Vol.7, No.6. pp. 531-541.

Kielpinski, G. (2003). Automated Sterility Testing: an Alternative Approach to Compendial Sterility Testing of Cell Therapy Products. ISCT Poster #127.

McDonald, C. P., S. Hartley, S. Robbins, et al. (1996). The use of the BacT/ALERT system for screening cord blood donations. ASM Abstract C5.

McDonald, C.P., Ray, A., Lowe, P., Hartley, S., Robbins, S. & Barbara, A.J. (1999). Bacteriological testing of volume reduced cord blood. ASM Abstract.

Paterne, B., Sabatini, C., Huyghe, G., Maquin, C., Mouillot, L., Tissier, M. (2006). External Quality Control of Cellular Products: The French Experience. Poster # 176, ISCT 2006 Annual Meeting, Berlin.

Perotti, C.G., Del Fante, C., Viarengo, G, et. al (2004). A new automated cell washer device for thawed cord blood units. Transfusion, Vol. 44: 900-906.

Ritter, M., Schwedler, J, et al., (2003, November). Bacterial Contamination of Ex Vivo Processed PBPC Products Under Clean Room Conditions. Transfusion, 2003, 43: 1587-1595.

Rule, P., Schilling, S., Turnley, R. (2006). Evaluation of a 7-Day Rapid Method Utilizing the BacT/ALERT® Microbial Detection System and a Bag Rinse Protocol for the Screening of Microbial Contamination in Human Tissue Samples as an Alternative to the Traditional 14-Day Swab Method. Poster #A26. AATB 2006 Annual Meeting, San Diego, California, USA.

Sparrow, R. (2004). Microbial Screening of UC Blood Units By An Automated Culture System: Effect of Delayed Testing on Bacterial Detection. Cytotherapy, Vol. 6; 1: 23-29.

Stanworth, S., Warwick, R., Fehily, D, et. al (2001). A international survey of unrelated umbilical cord blood banking. Vox Sanguinis, Vol. 80: 236-243.

Tsang, K.S., Li, K. et al. (2001). Dextran sedimentation in a semi-closed system for the clinical banking of umbilical cord blood. Transfusion, 2001, 41: 344–352.

Van Wagenen, H., Jacobs, C. (2006). Validation of Vitek 2 Compact for the Identification of Isolates from Human Cells, Tissues, and Cellular and Tissue Based Products and Environmental Cultures. Poster #A29, AATB 2006 Annual Meeting, San Diego, California, USA.

Vowels, M., Hadfield, K., Stylianou, J. (2005). Correlation Between the Thawed Cord Blood Unit (CBU) Bag and Pilot Tube: Implications for the Release of CB. Poster #89. ISCT 2005 Annual Meeting, Vancouver.

Wall, D., Gambell, P. et al. (2006). Determining and Evaluating Acceptable Microbial Contamination Rates for PBSC Processing. Poster # 266, ISCT 2006 Annual Meeting, Berlin.

Standards and Regulations

JACIE/FACT Standard for Hematapoietic Progenitor Cell Collection, Processing, & Transplantation 2nd Edition. (Adapted January 2005). International Society for Cellular Therapy.

Dykewicz, C, Jaffe, H., (October 20, 2000). Guidelines for Preventing Opportunistic Infections Among Hematopoietic Stem Cell Transplant Recipients. Recommendations of CDC, the Infectious Disease Society of America, and the American Society of Blood and Marrow Transplantation. MMWR. 49:RR10; 1-128.

Mintz, P., Lipton, K. (July 20, 2005). AABB Bulletin #05-08. Final Interim Standards for Cellular Therapy Product Services, 1st Edition. Reference Standard 5R-H (Processing Tests for Cellular Therapy Products).

European Pharmacopoiea Cell Therapy Guideline. (2.6.27) (July 2006). Effective date: January, 2007.

Draft Guidance for Industry. (December 2006). Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies.

The BacT/ALERT® Microbial Detection System is marketed for use in the detection of microorganisms in blood and other normally sterile body fluids, and in the detection of microorganisms in other sample matrices and for additional specific indications for use, as specified in the package inserts, operator’s manuals, and labeling of the specific components of the BacT/ALERT system. Customers who use the BacT/ALERT system in testing of sample types or for indications other than those described in the applicable package inserts and operator’s manuals do so at their own risk. Customer acknowledges and agrees that it is Customer’s sole and exclusive responsibility to validate the System for any such intended use, and to determine whether the System is suitable for that intended use. The performance of any validation studies, and the subsequent use of the System based on Customer’s studies shall be the Customer’s sole risk and responsibility. Performance characteristics for the BacT/ALERT system for any use outside the labeling, package insert, or operator’s manual have not been established.

This abbreviated bibliography, separated by key word, is provided to help you in your media selection.

To Aid in Your BacT/ALERT® Media Selection

bioMérieux S.A.F-69280 Marcy l’EtoileFranceTel: (33) 04 78 87 20 00Fax: (33) 04 78 87 20 90www.biomerieux.com

bioMérieux, Inc.595 Anglum RoadHazelwood, MO 63042-2320U.S.A.Tel: (800) 634-7656Fax: (800) 657-3053www.biomerieux-usa.com08

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