Biological Quality Control

Location: Hutchinson Building, CD-150
Contact phone: (206) 667-5838
Contact e-mail: rmanger@fredhutch.org

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), and biochemical analyses (SDS-PAGE, IEF, ELISA, RID, HPLC, total protein, and osmolality). Methods have been validated and elevated to a standard that provides regulatory (FDA) support for clinical studies.

Doing Business with Biologics Production

Hutchinson Building, CD-150
(206) 667-5838
rmanger@fredhutch.org

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