Stem Cell Processing (Stem Cells in Clinical Applications)

110 6.2 GMP Principles First, it is necessary to mention that GMP guidelines are not instructions or proce- dures to produce or ...

111 To date, there are no complete GMP guidelines for cell-based products, although some main principles should be noted during ...

112 Traceability : Records of manufacture to enable the complete history of a batch to be traced are retained. A system is avai ...

113 ISO 14644-1: Classifi cation of air cleanliness ISO 14644-2: Specifi cations for testing and monitoring to prove continued ...

114 Different to research laboratories or facilities, GMP facilities for cellular produc- tion are only investigated when some ...

115 In Europe, MSCs are considered as somatic cell therapy products, referred to as advanced therapy medicinal products (ATMPs), ...

116 fl uid (Guan et al. 2012 ). Traditionally, MNCs from peripheral blood, bone marrow, and umbilical cord blood can be isolated ...

117 tissue and use thereof and isolation of stromal vascular fraction from vascular tis- sues (IntelliCell BioSciences Inc., USA ...

118 Table 6.5 Kits and isolation systems for adipose tissue based on enzymes currently patented, published, or commercially avai ...

119 Table 6.6 Kits and isolation systems for adipose tissue based on nonenzymatic methods currently patented, published, or comm ...

120 withdrawal. Therefore, allogeneic blood has been used as a replacement. Allogeneic samples must be subjected to serological ...

121 dishes with a treated surface. In a clinical study, T75 or T125 fl asks showed more advantages than T25 fl asks. In suspensi ...

122 6.6.3 Harvesting Adherent Cells MSCs must be cultured as adherent cells in both monolayer and suspension culture. After expa ...

123 serum also has risks related to viral transmission or xenoprotein-related reactions. Auto-serum is suitable to replace anima ...

124 Although MSCs exhibit self-renewal, they also undergo senescence after long-term culture. MSCs typically proliferate for 20– ...

125 both USP (ch. 1223) and EP (Sect. 5.1.6). At present, there are some solutions for rapid microbiological testing, but all ha ...

126 liquid enrichment medium, from which mycoplasma cultures are transferred onto agar after several days. The second is cocultu ...

127 Bartosh TJ, Ylostalo JH, Mohammadipoor A, Bazhanov N, Coble K, Claypool K, Lee RH, Choi H, Prockop DJ (2010) Aggregation of ...

128 Hung SP, Ho JH, Shih YR, Lo T, Lee OK (2012) Hypoxia promotes proliferation and osteogenic differentiation potentials of hum ...

129 Tarte K, Gaillard J, Lataillade JJ, Fouillard L, Becker M, Mossafa H, Tchirkov A, Rouard H, Henry C, Splingard M et al (2010 ...