Production of a cellular product consisting of monocytes stimulated with Sylatron® (Peginterferon alfa-2b) and Actimmune® (Interferon gamma-1b) for human use

Table 4 Final release criteria

Test	Method	Acceptable limit
Appearance	Visual check	Normal–milky; no aggregates
% Viable monocytes (CD14+)	FACS	≥ 40%
Endotoxin	LAL assay	< 5EU/mL
Sterility on final product	Bacterial bottle cultures, fungal on plate cultures	No growth
Gram stain	Gram stain	No organism seen
Donor eligibility	NA	Auto

ISSN: 1479-5876