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Published in Michael Hehenberger, Zhi Xia, Huanming Yang, Our Animal Connection, 2020
Michael Hehenberger, Zhi Xia, Huanming Yang
Milstein and Köhler were able to turn the normally evil feature of tumor cells, the capacity to proliferate forever, into a very beneficial property: Using a technique to fish up antibody-producing cells from a sea of cells, they then fused these cells with mouse tumor cells and created hybrid cells with a capacity to produce the very same antibody in high quantity. They called these hybrid cells hybridomas. Since all cells in a given hybridoma come from one single hybrid cell, the antibodies made are monoclonal. The first application of “hybridoma technology” was to use a line of myeloma cancer cells and to fuse them with healthy antibody-producing B cells. Monoclonal antibody (mab) technology allowed scientists to grow huge quantities of pure antibodies aimed at specific selected targets, leading to the design of new diagnostic tests and therapeutics. By injecting a payload of mabs into the bloodstream, the antibodies were headed straight to their disease target.
Multiproduct Facility Design: An Integrated Approach
Published in Kenneth E. Avis, Vincent L. Wu, Biotechnology and Biopharmaceutical Manufacturing, Processing, and Preservation, 2020
In any facility in which multiproduct processing is contemplated, all stages of processing should be carefully assessed for their potential to affect or be affected by other processes. For example, a monoclonal antibody may be produced for several uses–as a potential therapeutic, an in vivo diagnostic, or an in vitro diagnostic. Following biosynthesis, antibody destined for different final products may follow different processing steps. Careful design would be needed to ensure that the different cGMP compliance requirements of the therapeutic and diagnostic products do not compromise each other. Radiolabeling, fluorescent tagging, solvent extraction, and chemical coupling processes, for example, should invariably be dedicated processes, removing the potential for cross-contaminating other processes.
Nonclinical Studies
Published in John M. Centanni, Michael J. Roy, Biotechnology Operations, 2016
John M. Centanni, Michael J. Roy
Biopharmaceuticals are sometimes given in large amounts to a single site on the body; most of them are injected. For example, a monoclonal antibody may be periodically injected subcutaneously in doses, each over 100 mg. A number of untoward reactions can result, and nonclinical study designs consider how local reactions are detected at the site of injection or deposition in an animal model. The mechanism of action can be quite different for each biopharmaceutical and tissue. Local immune and inflammatory reactions can result, especially after multiple doses, and these may be chronic or acute. Cells or vaccine antigens can, by product design, remain at the site of injection and cause problems that are not anticipated and are not immunologic, such as proliferation of fibrous or adipose tissue. A common method for studying tissue binding or local tissue tolerance is to add measurements of local reactivity to already designated acute, subchronic, and chronic toxicology protocols. In one example, tissue samples are taken periodically by biopsy and again at the time of sacrifice and studied for signs of local toxicity.
Production and characterization of a conserved M2e peptide-based specific IgY antibody: evaluation of the diagnostic potential via conjugation with latex nanoparticles
Published in Preparative Biochemistry and Biotechnology, 2018
Yasemin Budama-Kilinc, Rabia Cakir-Koc, Burak Ozdemir, Zeynep Kaya, Selim Badur
The production of influenza-A-specific antibody is a contemporary area regarding the importance and changeable structure of virus for human and veterinary health because of the lack of a completely efficient vaccine and restricted anti-viral drug options. Therefore, the constant regions such as M2e gain importance, and M2e-specific monoclonal antibodies have been produced and used for different purposes, e.g., to demonstrate the effect on the in vitro replication of certain influenza A strains.[56] The production of M2e-specific monoclonal antibodies is ongoing, and standard protocols have been applied to different M2e-specific antibody hybridomas to produce monoclonal antibodies. However, monoclonal antibody production is challenging, disadvantageous and causes distress to the animals during the collection of blood samples and sacrifice. Thus, the IgY antibody production has become a rising trend. A specific study on IgY production using the M2e peptide was conducted in this study for the first time in literature. According to the protein and antibody levels in the egg yolk, which were determined using a nano-spectrophotometer, a substantial number of antibodies were obtained using the IgY method. The ELISA results also demonstrate that M2e-specific antibodies were successfully obtained. The antibody levels increased after the first month, and a high amount of antibody was continuously obtained during the months. These results are consistent with the knowledge about the high amount of antibody production for a long time after several immunizations using the IgY method.[57–60]