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Quality Control

Quality Control

Bio X Cell is committed to providing translational and preclinical researchers with the highest-quality in vivo research tools, including monoclonal, bispecific, and biosimilar antibodies, as well as associated buffers. All Bio X Cell products are rigorously tested for quality, ensuring consistent performance, outstanding reliability, and exceptional lot-to-lot consistency.

Headquartered in the United States, we have over 25 years of antibody manufacturing experience. With a global distribution network, including supply centers in China and Germany, Bio X Cell is able to scale up with research needs wherever a lab is based. We have over 25,000 product citations in peer-reviewed journals, allowing you to trust that antibodies from Bio X Cell deliver consistent performance, resulting in publication-quality data.

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The Bio X Cell One-Year Shelf-Life Guarantee

We stand by the quality of our products and provide a no-hassle replacement or credit if an antibody does not perform as indicated on the datasheet. Please contact our technical support team or complete the Technical Service Request Form within 12 months of product receipt.

Precision and Care in Every Product

Each lot we produce is tested in various assays to ensure lot-to-lot consistency. Lot-specific quality control data is available upon request by contacting technical support.

Purity

Each lot of each antibody is checked for purity and integrity 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 its 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

Comparison of Bio X Cell’s Pathogen Testing Panels

Each lot of every applicable antibody is screened for an extensive panel of contaminants using a highly specific, ultra-sensitive real-time PCR-based assay.

PhaseMAP2
Mouse parvovirus (MPV)
Mouse minute virus (MVM)
Mouse hepatitis virus (MHV)
Theiler's murine encephalomyelitis (TMEV)
Sendai virus
Pneumonia virus of mice (PVM)
Mouse Norovirus (MNV)
Reovirus screen (REO)
Lymphocytic choriomeningitis virus (LCM)
Lactate dehydrogenase-elevating virus (LDEV)
Mouse rotavirus (EDIM)
Ectromelia/mousepox virus
Hantavirus
Polyoma virus
Mouse adenovirus 1 (MAD/V1)
Mouse cytomegalovirus (MCMV)
K Virus
Mouse adenovirus 2 (MAD/V2)
Mycoplasma

Isotype Confirmation

Each antibody lot 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 every 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

InVivoMAb™InVivoPlus™InVivoSIM™RecombiMAb™ReadyTagFlowMAb™
Catalog number formatBE####BP####SIM####CP###RT####FM###
Purity
Determined by SDS-PAGE
≥95%≥95%≥95%≥95%≥95%≥95%
IsotypeYesYesYesYesYesYes
Binding Validation*
Determined by immunoblot, flow cytometry, or ELISA
NoYesYesYesNoYes
Murine Pathogen Screening
Determined by ultrasensitive real-time PCR
NoYesYesYesNoNo
Antibody Aggregation Analysis
Determined by SDS-PAGE
NoYesYesYesNoNo
Endotoxin Testing
Determined by LAL gel clotting assay
≤1EU/mg≤0.5EU/mg≤0.5EU/mg≤0.5EU/mg≤1EU/mgNo
*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.

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