BIOSCOT Blood typing monoclonal antibodies

Millipore offers its BIOSCOT monoclonal antibodies in various forms from standarized intermediates, For Further Manufacturing Use (FFMU) or as finished reagents in bulk or unlabelled vials and even under full OEM arrangements.

» Read our full brochure...

Millipore has a deep reservoir of talent and particular expertise gathered over a twenty year period in the manufacture of monoclonal antibodies and finished blood typing reagents. This experience is now available to companies needing to produce antibodies for other diagnostic applications.

BIOSCOT Blood typing monoclonal antibodies

Millipore offers a wide range of BIOSCOT finished reagents compliant with the requirements of the European Directive 98/79/EC. Performance concerns are minimized as the potency of all BIOSCOT products match or exceed the potency required by the United States Food and Drug Administration (US FDA). The recommended methods of use include the tube, slide and microplate methods (for more details see previous table). In addition to a wide range of products, the BIOSCOT antibody portfolio offers a broad range of commercial options including the supply of finished reagent bulk or as unlabelled vials for resale purposes. Whether your product is Millipore labeled or private labeled (O.E.M.), Millipore can assist you with product and batch registration and/or CE marking when applicable. Furthermore, Millipore has a long history in assisting customers with obtaining product registrations in many countries.

» See Millipore's range of BIOSCOT finished reagent products...

BIOSCOT For Further Manufacturing Use (FFMU)

The BIOSCOT FFMU series from Millipore provides manufacturers with a wide range of standardized intermediate products. By dilution, blending (where appropriate) and chemical additions, manufacturers can create products with suitable reaction characteristics for their application(s). Most of the FFMU series of reagents are currently licensed with the US Food and Drug Administration Center for Biologics Research and Evaluation under shared manufacturing arrangements.

BIOSCOT 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. Millipore is able to offer technical support and guidance to assist manufacturers in obtaining maximum benefit from its FFMU Intermediates. In many ways, the BIOSCOT range of FFMU Intermediates is similar in usage to polyclonal source plasma. However, the products have major advantages in lot-to-lot reproducibility; in both potency and specificity; and have minimal processing requirements in that there is no absorption of unwanted antibodies or de-lipidization required. The potency of each batch is carefully controlled to match that of an internal reference batch.

Core products

To offer our customers a wider choice of ABO & D reagents, Millipore (formerly Celliance) is introducing the following range in response to demands we have received from some territories. We have eliminated the costs of product & batch registration associated with CE marking.

For users wishing to detect D category V1 we additionally recommend using the IgM/IgG blended anti-D (code NL) by the indirect Anti-human globulin method. By elimination of all the batch testing required to support use by microplate methods we have reduced our quality control testing regime. By passing these savings through to our customers we consider that these reagents offer excellent value for users who do not require CE marking or product support on the suitability of all batches for use in microplates.

The reagents are offered only as a pack of 100 X 10 mL vials. The potency of these reagents compares well with competitor products & technical information on the range is available from Technical Services.

NI – Core Anti-A (clone Birma-1)

This reagent will react avidly with A1, A2, A1B and A2B red cells. It will directly agglutinate most examples of Ax. It gives classic mixed field reactions with A3 and A3B cells.

NJ – Core Anti-B (clone LB-2)

This reagent will react avidly with B and AB red cells. It directly agglutinates examples of Bx. It does not agglutinate A1 red cells with the ‘acquired B antigen’.

NK – Core Anti-D IgM (clone Rum-1)

This reagent is particularly suitable for grouping patients. It does not agglutinate D category VI red cells. It will directly agglutinate normal, Dweak and most D partial types.

NL – Core Anti-D IgM/IgG (clones TH-28+MS-26)

This reagent is particularly suitable for grouping blood donations or neonates where detection of D category VI is desirable. The reagent directly agglutinates red cells with normal D expression and most examples of D weak and D partial, but not D category VI. When used by the indirect antihuman globulin method or by many automated methods the IgG component will agglutinate D category VI red cells.

Contact Us

Features

News & Releases

Millipore Forms New Diagnostics Strategic Business Unit