Quality Control
Precision and Care in Every Product
Bio X Cell emphasizes its commitment to delivering high-quality products through rigorous quality control testing, ensuring repeatable performance and reliability. With 25 years of experience in antibody manufacturing and over 20,000 product citations in peer reviewed publications, you can be confident that our antibodies will produce publication-quality data.
Our products are subjected to rigorous quality control testing to ensure the best possible performance and data reproducibility. To ensure lot-to-lot consistency, each lot we produce is tested in a variety of assays. All lot specific quality control data documentation is available upon request by emailing technicalservice@bioxcell.com.
Purity
Each lot of each antibody is checked for purity and integrity using SDS-PAGE analysis to ensure the purity level is ā„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 ā„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 includingĀ 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#### |
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 SupportĀ
If you have any questions about our quality control measures please contact us atĀ technicalservice@bioxcell.comĀ or visit ourĀ FAQĀ page.