Blood Typing

Merck is a leading provider of monoclonal antibodies to the blood typing market. Our large portfolio of standardized antibody intermediates for further manufacturing use (FFMU) and finished reagents allows manufacturers to create and manufacture a wide variety of blood typing reagents and devices. Our brand is globally synonymous with quality backed by our ISO-certified, FDA-licensed manufacturing facilities and experienced personnel. This enables us to stay in the forefront of the industry and ensures the quality of these antibodies to meet global regulatory requirements.

Blood typing intermediates for further manufacturing use (FFMU)

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.

Finished Blood Typing Reagents

Millipore^® portfolio of blood typing reagents are made from human or murine monoclonal antibodies and are formulated in low-protein diluents. These monoclonal reagents offer many advantages over polyclonal-based products.

• Highly specific – no risk of contaminating antibodies
• Lot-to-lot consistency
• Low biohazard risk
• IgM antibodies allow direct agglutination, react without the need for an indirect antiglobulin test, and can be used to type cells with a positive direct antiglobulin test.

We offer a large portfolio of finished reagents compliant with the requirements of the European Directive 98/79/EC. These reagents are offered in a wide range of commercial options, including bulk, reagents for research use, BIOSCOT^® labeled vials carrying the CE mark or unlabeled vials.

We have many years of experience in aiding customers in the registration of products in other countries, so whether your product is BIOSCOT^® labeled or in your own trade dress, we can support you with your product registration.

BIOSCOT^® labeled reagents are not available to customers in all geographies.

Bulk reagent, reagent for research and unlabeled vial formats share the same reactivity and attributes as our BIOSCOT^® CE marked reagents. Bulk reagent & unlabeled vial formats are for further manufacturing or non-diagnostic use. Reagents labelled for research use are not intended for use in clinical diagnostic applications.

Human IgG Monoclonal Antibodies for Research Use

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.