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The development of Bevacizumab (Avastin) biosimilar products has grown rapidly over the last ten years as the original Avastin's patent will expire soon. The approval of Avastin biosimilars requires the demonstration of similarity between the biosimilar and the reference product. To support pre-clinical and clinical studies, pharmacokinetic (PK) assays are required to measure the biosimilar and Avastin with comparable precision and accuracy. The PK assay of Avastin employed by Genentech was a Sandwich ELISA which could detect the total drug concentration. However, it was developed in-house and not commercially available. Therefore, in most of the Avastin biosimilar pre-clinical studies, the antibody drug concentrations were measured using an indirect ELISA against coated VEGF, which could only measure the free instead of the total antibody drugs. It failed the essential requirement to develop the biosimilars. In this study, we reported the generation of mouse monoclonal antibodies (mAbs) that specifically recognize Avastin in a VEGF non-competitive manner. Using a pair of non-VEGF competing anti-Avastin mAbs, a Sandwich ELISA was developed with a lower limit of quantitation (LLOQ) at 400 ng/mL and upper limit of quantitation (ULOQ) at 12800 ng/mL. The assay validation was carried out with serum samples from monkey treated with Avastin biosimilar at seven different time points. Our data showed that the Sandwich ELISA kit we developed is sensitive, simple, reproducible and ready for use in human clinical trials.
This article was published in the following journal.
Name: Journal of immunological methods
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Antibodies obtained from a single clone of cells grown in mice or rats.
Antibodies produced by clones of cells such as those isolated after hybridization of activated B LYMPHOCYTES with neoplastic cells. These hybrids are often referred to as HYBRIDOMAS.
Antibodies from non-human species whose protein sequences have been modified to make them nearly identical with human antibodies. If the constant region and part of the variable region are replaced, they are called humanized. If only the constant region is modified they are called chimeric. INN names for humanized antibodies end in -zumab.
Antibodies, often monoclonal, in which the two antigen-binding sites are specific for separate ANTIGENIC DETERMINANTS. They are artificial antibodies produced by chemical crosslinking, fusion of HYBRIDOMA cells, or by molecular genetic techniques. They function as the main mediators of targeted cellular cytotoxicity and have been shown to be efficient in the targeting of drugs, toxins, radiolabeled haptens, and effector cells to diseased tissue, primarily tumors.
A malignancy of mature PLASMA CELLS engaging in monoclonal immunoglobulin production. It is characterized by hyperglobulinemia, excess Bence-Jones proteins (free monoclonal IMMUNOGLOBULIN LIGHT CHAINS) in the urine, skeletal destruction, bone pain, and fractures. Other features include ANEMIA; HYPERCALCEMIA; and RENAL INSUFFICIENCY.
Monoclonal antibodies MAbs
Monoclonal antibodies recognise and attach to specific proteins produced by cells. Types of monoclonal antibodies used to treat cancer cells: Block cell dividing dividing signals Transport cancer drugs or radiation to cancer cells Tr...
An antibody is a protein produced by the body's immune system when it detects harmful substances, called antigens. Examples of antigens include microorganisms (such as bacteria, fungi, parasites, and viruses) and chemicals. Antibodies may be produc...
Biosimilars or Follow-on biologics are terms used to describe officially approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product. Products that ar...