Millipore® portfolio of blood typing intermediates for further manufacturing use (FFMU) are standardized cell culture supernatants from cell lines expressing human or murine monoclonal antibodies. These FFMU intermediates are for use in formulating finished blood typing reagents or devices. By dilution, blending (where appropriate) and chemical additions, manufacturers can formulate their own finished reagents or devices with reactivity profiles suitable for their specific applications. The potency of each batch is carefully controlled to match that of an internal reference batch. All FFMUs contain 0.1% (w/v) sodium azide as a preservative.
Most of the FFMU series of antibodies are currently licensed with the US Food and Drug Administration under shared manufacturing arrangements.
The Human IgG Monoclonal Antibodies for Research Use are clarified cell culture supernatants from cell lines expressing Human IgG monoclonal blood typing antibodies that are reactive by an indirect antiglobulin test method. These products are intended for use by manufacturers wishing to make non-IVD reagents or devices such as proficiency kits, internal test controls or educational samples.