Articles by Tosoh Bioscience LLC - BioPharm International

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Articles by Tosoh Bioscience LLC

Tosoh Bioscience LLC


Articles
Purification of a Monoclonal Antibody with TOYOPEARL® AF-rProtein A HC-650F at Various Bed Heights
November 25, 2014

Scientists use a variety of column dimensions in terms of internal diameter and length when developing a Protein A purification step for monoclonal antibody capture. Typical bed heights for Protein A columns used in a commercial manufacturing process are in the range of 15 to 20 cm to optimize throughput, yield, and recovery to make the production as efficient and cost effective as possible. Here, we show that altering column dimensions to favor a shorter, wider column will have no effect on resin performance when compared with a longer, narrower column of the same total volume.

CaPure-HA Resin for Aggregate Removal from Monoclonal Antibodies
November 25, 2014

Scientists in the field of process chromatography methods development are constantly on the lookout for better and more selective ways to remove aggregates and other process-related impurities from monoclonal antibody monomer. The data presented in the following paper demonstrate the capabilities of CaPure-HA to remove degradation products, dimer, and higher-order aggregates from the monomer of a Protein A-purified IgG1 monoclonal antibody.

CaPure-HA Resin for Aggregate Removal from Monoclonal Antibodies
October 28, 2014

Scientists in the field of process chromatography methods development are constantly on the lookout for better and more selective ways to remove aggregates and other process-related impurities from monoclonal antibody monomer. The data presented in the following paper demonstrate the capabilities of CaPure-HA to remove degradation products, dimer, and higher-order aggregates from the monomer of a protein A purified IgG1 monoclonal antibody.

TOYOPEARL GigaCap® Cation Exchange Resins for Aggregate Removal from Monoclonal Antibodies
August 26, 2014

Aggregate removal is a pivotal process step in the purification of monoclonal antibodies (mAbs). The removal of soluble, non-precipitated mAb aggregates is highly challenging due to their close physical and chemical similarity to the drug product itself. Ion exchange chromatography (IEC) has long been used as an effective means of removing process impurities from biological drug products. Cation exchange chromatography (CEX), in particular, has shown to be effective in separating mAb monomer from dimers and higher order aggregates. In this paper, the removal of mAb dimer and higher order aggregates from mAb monomer using TOYOPEARL GigaCap cation exchange resins is demonstrated.

TOYOPEARL NH2-750F Aggregate Removal from Monoclonal Antibodies
June 24, 2014

The drive to reduce the manufacturing costs for biological therapeutics have increased the demands placed on downstream unit operations to the point where a single processing step is expected to accomplish a multitude of purification objectives. Where anion exchange resins have traditionally been used to remove DNA, endotoxin, and as a viral clearance step in the purification of monoclonal antibodies (mAbs), new ligand chemistries make it possible for anion exchange chromatography to do more. In the following paper, TOYOPEARL NH2-750F, a salt tolerant anion exchange resin from Tosoh Bioscience, is shown to be able to remove mAb dimer and higher order aggregates from mAb monomer.

TOYOPEARL® AF-rProtein A HC-650F rProtein A Ligand Leakage
May 26, 2014

This application note compares the amount of leached Protein A ligand that is present in purified monoclonal antibody, post elution, when using TOYOPEARL AF-rProtein A HC-650F, TOYOPEARL AF-rProtein A-650F, and another commercially available high capacity Protein A resin. Protein A ELISA tests specific to each resin evaluated show that the TOYOPEARL AF-rProtein A HC-650F is very stable and exhibits a markedly lower level of ligand leakage compared to the other resins tested.

TOYOPEARL AF-rProtein A HC-650F Host Cell Protein Removal
March 25, 2014

The following paper compares the host cell protein (HCP) removal capabilities of TOYOPEARL AF-rProtein A HC-650F, TOYOPEARL AF-rProtein A-650F, and another commercially available high-capacity protein A resin.

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