Dominic Wall
Dominic Wall
Dominic Wall
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Quality by release certificate<br />
or by PAT?<br />
Day 6 (Pre)<br />
Day 6 (Post)<br />
Final Fill (Aliquoting)<br />
Final Product<br />
Mycoplasma:Local Regulatory Requirements (EMA, FDA or TGA): not<br />
detected<br />
FACS: Total Viable DC: ≥<br />
Viability: ≥ 70%<br />
%DC : Information only<br />
Appearance:<br />
Volume:<br />
Container Label:<br />
FACS: Total Viable DC x%<br />
Phenotype DC : Information only<br />
% Non DC: in CD45+ cells: FIO<br />
Sterility: As per Local Regulatory Requirements (EMA, FDA or TGA): No<br />
bacterial or fungal contamination detected<br />
Endotoxin: As per Local Regulatory Requirements (EMA, FDA or TGA)<br />
Potency: Bioassay : Information only
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