Various analytical methods are utilized to insure that products meet defined release specifications and acceptance criteria. Testing includes; analyses for microbial contaminants (bioburden, sterility, microbial identification, mycoplasma, and endotoxin), biochemical analyses (SDS-PAGE, IEF, ELISA, RID, HPLC, total protein, and osmolality), and/or cell product characterization (cell counts/viability, flow cytometry, phenotyping, purity, colony-forming activity, and functionality). Methods have been validated and elevated to a standard that provides regulatory (FDA) support for clinical studies.
