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Quality Control

Purity

Each lot of each antibody is checked for purity and integrity using SDS-PAGE analysis to ensure the purity level is ≥95%.

SDS-PAGE Antibody Purity Assessment Example

Binding Validation

Each lot of each applicable antibody is screened for binding specificity against it's antigen and a negative control antigen via immunoblot. For select products we also ensure binding using flow cytometry.

Immunoblot Antibody Binding Validation Example

Flow cytometry Antibody Binding Validation Example

Antibody Aggregation Analysis

Each lot of each applicable antibody is analyzed using size exclusion chromatography (SEC) to determine the aggregate level and ensure a monomer content of ≥95%.

SEC Antibody Aggregation Assessment Example

Murine Pathogen Screening

Each lot of each applicable antibody is screened for an extensive panel of murine viruses as well as mycoplasma using a highly-specific ultra-sensitive real-time PCR based assay.Murine pathogen screening includes:

Mycoplasma including M. pulmonis, M. arginini, M. fermentans, M. hominis, M. hyorhinis, M. orale, M. pirum, M. salivarium, M. agassizii, M. cynos and others.Murine norovirus (MNV), murine parvovirus (MPV) 1, 2, 3, 4, and 5, murine minute virus (MMV/MVM), murine hepatitis virus (MHV), murine reovirus (REO) type 1, 2, and 3, lymphocytic choriomeningitis virus (LCMV), lactate dehydrogenase elevating virus (LDV), murine rotavirus MRV/EDIM), Theiler's murine encephalomyelitis virus (TMEV), ectromelia virus (ECTRO), hantavirus (HANTA), polyoma virus (POLY), murine adenovirus (detects and differentiates MAD1 and MAD2), sendai virus (SEND), pneumonia virus of mice (PVM), murine cytomegalovirus (MCMV) 1 and 2 (MCMV), and K virus.

Isotype Confirmation

Each lot of each antibody is isotyped using a rapid lateral flow antibody isotyping assay ensuring that the antibody is the correct host species, isotype class, subtype class, and light-chain identity.

Endotoxin Testing

Each lot of each antibody is screened and ensured to be ultra-low in bacterial endotoxin using the Limulus Amebocyte Lysate (LAL) gel clotting assay.

Detailed Breakdown of Quality Control Assays Included for each Product Line

Purity
Determined by SDS-PAGE
>95% >95% >95% >95% >95%
Isotype Confirmation Yes Yes Yes Yes Yes
Binding Validation*
Determined by imunoblot, flow cytometry, or ELISA
No Yes Yes Yes No
Murine Pathogen Screening
Determined by ultrasensitive real-time PCR
No Yes Yes Yes No
Antibody Aggregation Analysis
Determined by SEC
No Yes Yes Yes No
Endotoxin Testing
Determined by LAL gel clotting assay
<2EU/mg <1EU/mg <1EU/mg <1EU/mg <2EU/mg
Catalog number format BE#### BP#### SIM#### CP### RT####

*Binding validation is performed for each lot for all applicable InVivoPlus™ products. Non-applicable InVivoPlus™ products include antibodies for which an antigen is not commercially available and isotype control antibodies with unknown specificity.

The Bio X Cell One-Year Shelf-Life Guarantee

We stand by the quality of our products. In the rare event that an antibody does not perform as indicated on the datasheet, we provide a no-hassle replacement or credit. Please contact our technical support team or fill out the Technical Service Request Form within 12 months of product receipt.

Technical Support 

If you have any questions about our quality control measures please contact us at technicalservice@bioxcell.com or visit our FAQ page.