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Our mission is to provide the highest quality research products available, so that you can get reliable results quickly, easily, and consistently. Antibody products from BioLegend are manufactured in our San Diego facility by our expert staff. We are now operating under an ISO 9001:2008 and ISO 13485:2003 certified quality management system, that ensures that all customers get high quality products, superior customer support, and outstanding value.
Standard Operating Procedures (SOPs) are followed at each step of production. Every production SOP is developed through optimization and is validated by subsequent testing. Batch records are required and documented for every batch of production from cell culture/ascites production to purification, conjugation, bottling and packaging. In addition, every stage of production is well documented in an electronic database to maintain accuracy as well as to allow traceability.
Purified antibodies are produced by affinity purification methods. To ensure reproducibility, each cell line (clone) has defined cell culture specifications and purification specifications, such as resins for purification, elution condition, and final storage buffer. Each batch of purified material is tested for purity by SDS-PAGE and IEF gel analysis. Purity is required to be ≥ 95% for IgG. Endotoxin is tested by the LAL testing method for LEAF™ (Low Entotoxin Azide Free) Purified antibodies. While all LEAF™ products are guaranteed to be below 0.10 EU/µg of protein, most actually have endotoxin levels well below 0.10 EU/µg of protein. If your endotoxin requirements are more stringent, BioLegend may be able to provide products with endotoxin as low as 0.001 EU/µg of protein. The specificity and activity (titer) of purified materials are tested according to QC specifications (see below for further explanation). A batch of antibody can be released only if it passes all above required testing.
Conjugate products are manufactured by following defined conjugation SOPs and specifications. Critical raw materials are fully evaluated and validated for antibody conjugation usage. Each batch of critical materials is tested and meets its specifications before release for production. Each batch of conjugated product goes through physical testing such as dye to antibody ratios and dye to dye ratios (for tandem dye conjugates) to ensure these parameters meet the production specifications and to ensure lot to lot consistency of each antibody-fluorochrome conjugate. The functional activity of each conjugate product is tested for its intended application.
The specificity of each antibody is thoroughly validated in the New Product Development stage. This is done by staining multiple target cells with either single- or multi-color analysis or by other testing approaches. The QC specifications and testing SOPs of each product are then developed. The results are compared to the known published values.
The functional performance of each batch of BioLegend products is strictly QC-tested according to the established QC procedures. In general, each product is tested using the following criteria:
Staining of 1-3 target cell types with either single- or multi-color analysis specified in QC specification (including positive and negative target cells). The tested cells can be primary cells and/or cell lines known to be positive or negative for the target antigen.
Each batch product is validated by pre- and post-bottling QC testing with a series of dilutions to make sure the product is working within expected antibody titer range.
CD4-PE titration on normal human peripheral blood lymphocytes ranging from 2.0 - 0.015 µg/test.
Each batch is compared to an internally established "gold standard" to maintain batch-to-batch consistency.
When applicable, our products are side-by-side tested with our competitors' products to make sure that BioLegend's products exceed or are at least the same quality.
For tandem dye-conjugated products, color compensation is always examined in order to verify fluorescence emission at the appropriate wavelengths.
Hybridoma cell line verified to be producing antibody and is monoclonal.
Isotype testing and verification.
Purification testing: SDS-PAGE and IEF at 95% purity.
Endotoxin testing for LEAF™ Purified antibodies: Endotoxin level is < 0.10 EU/µg of the protein (< 0.01 ng/µg of the protein) as determined by the LAL test.
Post conjugation testing:
F/P ratio, dye/dye ratio for tandems.
Specificity testing based on known target cells and known specification comparing to a gold standard, also tested on negative cell targets.
Post bottling testing to verify the specificity is within the defined QC specs based on the SOP for the antibody.
