Packaging considerations for biopreservation

Transfusion Medicine and Hemotherapy

Volumn 38, Issue 2, 2011, Pages 149-156

  Woods, Erik J ^a,b   Thirumala, Sreedhar ^a  

^a General BioTechnology LLC   (United States)

^b INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Biopreservation; Closed system cryovials; Cryopreservation; Fill finish; Manufacturing; Mesenchymal stem cells; Scaleable; Vials

Indexed keywords

CELL THERAPY AGENT;

BLOOD BANK; CAREGIVER; CELL VIABILITY; CRYOPRESERVATION; HUMAN; MESENCHYMAL STEM CELL; NONHUMAN; PACKAGING; PRESERVATION; REVIEW; SEALED CONTAINER;

EID: 79953236211     PISSN: 16603796     EISSN: None     Source Type: Journal    
DOI: 10.1159/000326083     Document Type: Review

References (32)

1. Kirouac DC, Zandstra PW: The systematic production of cells for cell therapies. Cell Stem Cell 2008; 3:369-381.
2. Woods EJ, Perry BC, Hockema JJ, Larson L, Zhou W, Goebel WS: Optimized cryopreservation method for human dental pulp derived stem cells and their tissues of origin for banking and clinical use. Cryobiology 2009;59:150-157.
3. Akers MJ, Nail SL, Saffell-Clemmer W: Top ten topics in parenteral science and technology. PDA J Sci Technol 2007;61:337-361.
4. Eakins MN: New plastics for old vials. Bioprocess Int 2005;3:52-58.
5. Kempe MD, Jorgensen GJ, Terwilliger KM, McMahon TJ, Kennedy CE, Borek TT: Acetic acid production and glass transition concerns with ethylenevinyl acetate used in photovoltaic devices. Solar Energy Materials Solar Cells. 2007;91:315-329. (Pubitemid 44880119)
6. Fountain D, Ralston M, Higgins N, Gorlin JB, Uhl L, Wheeler C, et al: Liquid nitrogen freezers: A potential source of microbial contamination of hematopoietic stem cell components. Transfusion 1977;37:585-591.
7. Khuu HM, Cowley H, David-Ocampo V, et al: Catastrophic failures of freezing bags for cellular therapy products: Description, cause, and consequences. Cytotherapy 2002;4:539-549. (Pubitemid 36050192)
8. Thirumala S, Goebel WS, Woods EJ: Clinical grade adult stem cell banking. Organogenesis 2009;5:143-154.
9. Messori M, Toselli M, Pilati F, Fabbri E, Fabbri P, Pasquali L, Nannarone S: Prevention of plasticizer leaching from PVC medical devices by using organic- inorganic hybrid coatings. Polymer 2004;45:805-813. (Pubitemid 38155978)
10. Qadry SS, Roshdy TH, Char H, Del Terzo S, Tarantino R, Moschera J: Evaluation of CZ-resin vials for packaging protein-based parenteral formulations. Int J Pharm 2003;252:207-212. (Pubitemid 36126629)
11. Esfandiary R, Joshi SB, Vilivalam V, Middaugh CR: Characterization of protein aggregation and adsorption on prefillable syringe surfaces. Presented at the AAPS National Biotechnology Conference, Toronto, June 22-25, 2008.
12. Waxman L, Vilivalam V: Development of analytical techniques to determine protein adsorption on sterilized parenteral packaging containers and stoppers. Presented at AAPS National Biotechnology Conference. Seattle, WA, June 21-24, 2009.
13. Shin JY, Park JY, Liu C, He J, Kim SC: Chemical structure and physical properties of cyclic olefin copolymers. International Union of Pure and Applied Chemistry (IUPAC) Technical Report. Pure Appl Chem 2005;77:801-814. (Pubitemid 40937728)
14. Risbud MV, Hambir S, Jog J, Bhonde R: Biocompatibility assessment of polytetrafluoroethylene/ wollastonite composites using endothelial cells and macrophages. J Biomater Sci Polym Ed 2001;12: 1177-1189. (Pubitemid 34134188)
15. Shi S, Robey PG, Gronthos S: Comparison of human dental pulp and bone marrow stromal stem cells by cDNA microarray analysis. Bone 2001;29: 532-539. (Pubitemid 33124295)
16. Perry BC, Zhou D, Xiaohua W, Yang FC, Byers MA, Chu TM, Hockema JJ, Woods EJ, Goebel WS: Collection, cryopreservation and characterization of human dental pulp derived mesenchymal stem cells for banking and clinical use. Tissue Eng 2008;14:149-156. (Pubitemid 351838712)
17. Woods EJ, Bagchi A, Goebel WS, Vilivalam VD, Vilivalam VD: Container system for enabling commercial production of cryopreserved cell therapy products. Regen Med 2010;5:659-667.
18. Seo BM, Miura M, Sonoyama W, Coppe C, Stanyon R, Shi S: Recovery of stem cells from cryopreserved periodontal ligament. J Dental Res 2005; 841:907-912. (Pubitemid 43827798)
19. Zhang W, Walboomers XF, Shi S, Fan M, Jansen JA: Multilineage differentiation potential of stem cells derived from human dental pulp after cryopreservation, Tissue Eng 2006;12:2813-2823. (Pubitemid 46141249)
20. Freshney RI: Culture of Animal Cells: A Manual of Basic Technique. New York, Wiley and Sons, 2000.
21. Dominici M, Le Blanc K, Mueller I, Slaper-Cortenback I, Marini FC, Krause DS, Deans RJ, Prockop DJ, Horwitz EM: Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy 2006;8:315-317.
22. Shafer TW, Everett J, Silver GH, Came PE: Biohazard: Virus-contaminated liquid nitrogen. Science 1976;191:24-26.
23. Tedder R, Zuckerman M, Goldstone A, Hawkins A, Fielding A, Briggs E, Irwin D, Blair S, Gorman A, Patterson K, Linch D, Heptonstall J, Brink N: Hepatitis B transmission from contaminated cryopreservation tank. Lancet 1995;346:137-140.
24. Hawkins A, Zuckerman M, Briggs M, Gilson R, Goldstone A, Brink N, Tedder R: Hepatitis B nucleotide sequence analysis: Linking an outbreak of acute hepatitis B to contamination of a cryopreservation tank. J Virol Methods 1996;60:81-88. (Pubitemid 26188323)
25. Jones SK, Darville JM: Transmission of virus particles by cryotherapy and multi-use caustic pencils: A problem to dermatologists? Br J Dermatol 1989; 121:481-486. (Pubitemid 19251475)
26. Goodman J: Liquid nitrogen therapy of warts and other skin lesions. Can Med Assoc J 1960;82:628-630.
27. Charles CR, Sire DJ: Transmission of papillomavirus by cryotherapy application. J Am Med Assoc 1971;218:1435.
28. Prince H, Page S, Keating A, Saragosa R, Yukovic N, Imrie K, Crump M, Stewart A: Microbial contamination of harvested bone marrow and peripheral blood. Bone Marrow Transplant 1995;15:87-91.
29. Lazarus H, Magalhaes-Silverman M, Fox R, Creger R, Jacobs M: Contamination during in vitro processing of bone marrow for transplantation: Clinical significance. Bone Marrow Transplant 1991;7:241-246.
30. Stroncek D, Fautsch S, Lasky L, Hurd D, Ramsay N, McCullough J: Adverse reactions in patients transfused with cryopreserved marrow. Transfusion 1991;31:521-526.
31. Webb I, Coral F, Anderson J, Elias A, Finberg R, Nadler L, Ritz J, Anderson K: Sources and sequelae of bacterial contamination of hematopoietic stem cell components: Implications for the safety of hematotherapy and graft engineering. Transfusion 1996;36:782-788. (Pubitemid 26318182)
32. Thyagarajan B, Berger M, Sumstad D, McKenna DH Jr: Loss of integrity of umbilical cord blood unit freezing bags: Description and consequences. Transfusion 2008;48:1138-1142. (Pubitemid 351793499)