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Blood Typing Monoclonal Antibodies

For 25 years Millipore has been the leader in the development of monoclonal antibodies for the blood typing market. Millipore offers the largest stable of human IgM monoclonal antibodies available today. Millipore’s brand is globally synonymous with quality. Our ISO certified and FDA licensed, state of the art cGMP manufacturing facilities and experienced personnel enable us to stay in the forefront of this industry.

Millipore offers its range of monoclonal antibodies in various forms, from standardized intermediates, For Further Manufacturing Use (FFMU), to finished reagents in bulk, unlabeled vials or full customer-specific trade dress.

Monoclonal Antibodies For Further Manufacturing Use (FFMU)

FFMU Intermediates are standardized solutions of monoclonal antibodies for use in the formulation of finished blood typing reagents. By dilution, blending (where appropriate) and chemical additions, manufacturers can formulate their own finished reagents with reactivity profiles suitable for their specific applications.

In many ways, the Millipore range of FFMU Intermediates is similar in usage to polyclonal source plasma. However, the products have major advantages in lot-to-consistency— in both potency and specificity, and have minimal processing requirements—no defibrination, delipidisation or absorption of unwanted anibodies. 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.

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BIOSCOT Blood Typing Reagents

Millipore’s 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. These advantages include:

  • 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.

Millipore offers a wide range of monoclonal blood typing finished reagents compliant with the requirements of the European Directive 98/79/EC. The BIOSCOT portfolio is supplied in a variety of commercial configurations: finished reagent bulk, unlabeled vials, or private trade dress. Whether the product is Millipore labeled or privately labeled (OEM), Millipore can assist with product and batch registration and/or CE marking where applicable.

BIOSCOT labeled reagents are not available to customers in the US or Canada.

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