Anti-rabies monoclonal antibodies and cocktail thereof
A technology of monoclonal antibody and cloning antibody, which is applied in the direction of antibodies, antiviral agents, antibody medical components, etc., and can solve problems such as the inability to provide high anti-rabies virus protection
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Embodiment 1
[0192] Example 1: Manufacture of Monoclonal Antibody mAbA Active Drug Substance
[0193] The drug substance manufacturing process for mAbA monoclonal antibodies involves—
[0194] - Upstream Sp2 / 0 cell culture process, and
[0195] - Downstream purification process.
[0196] produce mAb A Upstream culture process of monoclonal antibody
[0197]mAb A monoclonal antibody is produced by the host cells of the expression system during the culture of Sp2 / 0 cells in the presence of animal origin-free medium and feeder components. Media containing serum components can also be used to raise the antibodies. Each batch production upstream begins with resuscitation of the contents of a master cell bank (MCB) or working cell bank (WCB) vial of Sp2 / 0 cells bearing the mAb A polynucleotide sequence. Following resuscitation of the cell bank vials, a series of inoculum development steps were performed to generate a final inoculum with sufficient numbers of cells to inoculate into produ...
Embodiment 2
[0208] Example 2: Manufacture of mAb B Monoclonal Antibody Active Drug Substance
[0209] The drug substance manufacturing process for mAb B monoclonal antibody involves—
[0210] - Upstream Sp2 / 0 cell culture process, and
[0211] - Downstream purification process.
[0212] Upstream culture process for production of mAb B monoclonal antibody
[0213] mAb B monoclonal antibody is produced during cell culture by host cells expressing the system Sp2 / 0 in the presence of animal origin-free medium and feed components. Media containing serum components can also be used to raise the antibodies. Each batch production upstream begins with recovery of the contents of a master cell bank (MCB) or working cell bank (WCB) vial of Sp2 / 0 cells bearing the mAb B polynucleotide sequence. Following resuscitation of the cell bank vials, a series of inoculum development steps were performed to generate a final inoculum with sufficient numbers of cells to inoculate into production bioreactor...
Embodiment 3
[0225] Example 3: Preparation of Antibody Mixtures Comprising Equivalent Antibodies
[0226] The purified drug substances of mAb A and mAb B were assigned potency values in IU / mg by performing the RFFIT test in order to prepare antibody mixtures containing equivalent amounts of both antibodies. The individual drug substances mAb A and mAb B were diluted on a concentration (mg / mL) basis by pH 6.0 citrate buffer containing sodium chloride and polysorbate to achieve similar potency values in IU / mL. To prepare antibody mixtures comprising equivalent antibodies, both the diluted drug substances of mAb A and mAb B are mixed appropriately.
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