Food and Drug Administration, Department of Health and Human Services. Current good tissue practice for human cell, tissue, and cellular and tissue-based product establishments; Inspection and enforcement (21 CFR Parts 16, 1270, and 1271). Fed Regist, 2004; 69:68612–68688.
2.
Food and Drug Administration. Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Rockville, MD: Author; 2009. http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm062693.htm.
3.
GinsburgGS, BurkeTW, FebboP.Centralized biorepositories for genetic and genomic research. JAMA, 2008; 299:1359–1361.
4.
ISBER. 2008 Best practices for repositories. Cell Preserv Technol, 2008; 6:3–58.
5.
MitchellBL, YasuiY, LiCI, et al. Impact of freeze-thaw cycles and storage time on plasma samples used in mass spectrometry based biomarker discovery projects. Cancer Infor, 2005; 1:98–104.
6.
ClarkJ.Risk management in the biomaterial cold chain. Contract Pharma. Nov/Dec 2006. http://www.contractpharma.com/articles/2006/11/risk-management-in-the-biomaterial-cold-chain.
7.
U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, and National Institutes of Health. Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th ed. Washington, DC: US Government Printing Office; 2007.