GMP Compliant Production of a Cryopreserved Adipose-Derived Stromal Cell Product for Feasible and Allogeneic Clinical Use

<table class="table-group" id="tab2"><tr><td><table class="table"><tr><td class="thead-hr" colspan="3"><hr/></td></tr><tr class="thead"><td class="align_left">Attribute</td><td class="align_center">Method of analysis</td><td class="align_center">Acceptance criteria</td></tr><tr><td class="thead-hr" colspan="3"><hr/></td></tr><tr><td class="align_left" rowspan="2">Donor screening</td><td class="align_center">Serology (antibody testing)</td><td class="align_center">Negative for anti-HIV1, 2 anti-HCV, HBsAg, anti-HBc, syphilis, HTLV I/II</td></tr><tr><td class="align_center">Nucleic acid amplification technique (NAT, antigen testing)</td><td class="align_center">Negative for HIV, HBV, and HCV</td></tr><tr><td class="align_center" colspan="3"><hr/></td></tr><tr><td class="align_left" rowspan="3">Sterility</td><td class="align_center">Bacteria/fungus: BACT/ALERT microbial detection system (aerobic and anaerobic)</td><td class="align_center">Negative/negative</td></tr><tr><td class="align_center">Bacterial endotoxin (LAL, method D)</td><td class="align_center">&lt;70 IU/ml</td></tr><tr><td class="align_center">Mycoplasma (NAT)</td><td class="align_center">Negative</td></tr><tr><td class="align_center" colspan="3"><hr/></td></tr><tr><td class="align_left" rowspan="5">Identity and purity</td><td class="align_center" rowspan="5">Flow cytometry</td><td class="align_center"><span style="width: 68.2096ptpx;"><svg height="9.39034pt" id="M6" style="vertical-align:-0.6370001pt" version="1.1" viewbox="-0.0498162 -8.75334 68.2096 9.39034" width="68.2096pt" xmlns="http://www.w3.org/2000/svg" xmlns:xlink="http://www.w3.org/1999/xlink"><g transform="matrix(.013,0,0,-0.013,0,0)"><path d="M614 175C564 76 510 21 408 21C256 21 146 149 146 336C146 488 235 629 402 629C510 629 570 586 597 480L626 488C620 541 614 582 606 638C578 643 510 665 429 665C206 665 44 527 44 316C44 157 153 -15 402 -15C474 -15 558 5 586 11C604 45 629 119 643 165L614 175Z"></path></g><g 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39 119 71 97 89C88 97 80 96 71 90C59 80 50 67 49 57C48 45 52 36 66 23C80 9 123 -12 169 -12C221 -11 288 15 342 59C403 109 431 165 431 225C431 308 366 395 238 395C212 395 165 379 127 364L153 550Z"></path></g><g transform="matrix(.013,0,0,-0.013,38.712,0)"><path d="M594 629L561 652L159 -9L190 -32L594 629ZM194 635C92 635 49 534 49 453C49 374 92 272 193 272C295 272 338 374 338 454S295 635 194 635ZM193 605C257 605 265 504 265 453C265 405 257 302 194 302C133 302 122 403 122 454S133 605 193 605ZM567 351C465 351 421 250 421 169C421 90 465 -12 566 -12S710 90 710 170S667 351 567 351ZM566 322C628 322 637 221 637 169C637 121 628 18 567 18S494 119 494 170C494 223 506 322 566 322Z"></path></g></svg></td></tr><tr><td class="align_center" colspan="3"><hr/></td></tr><tr><td class="align_left">ASC viability</td><td class="align_center">Nucleocounter NC100</td><td class="align_center">&gt;80%</td></tr><tr class="table-tr"><td colspan="3"><hr class="tbody-hr"/></td></tr></table></td></tr></table>

Stem Cells International

tab2

Table 2

Table 2: GMP Compliant Production of a Cryopreserved Adipose-Derived Stromal Cell Product for Feasible and Allogeneic Clinical Use 