Author Archives: R. Christopher Manzari

TOYOPEARL® AF-rProtein A HC-650F: Economic Advantages of Using a High Capacity Protein A Resin

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TOYOPEARL AF-rProtein A HC-650F and two other commercially available protein A resins (one of them also a “high capacity†resin) were compared on a cost-per-gram of monoclonal antibody (mAb) produced basis at multiple resin prices from $7,000 to $17,000 per liter as well as three different column configurations. For in-depth comparison, the median resin price of $12,000 per liter was used as a basis to determine comparative production costs among the three resins tested. The configuration used to model what…

August 10, 2016

CaPure-HAâ„¢: DoE Optimization of Elution Conditions

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Design of Experiments (DoE), also called experimental design, is a statistical approach to process development that has gained wide acceptance in the biopharmaceutical industry. DoE is used to reduce development costs by speeding up the design process and to optimize the parameters of a particular step in the manufacturing process. With its inherent ability to take into account multiple variables at once, a designed experiment is also used to minimize process variation leading to a more robust manufacturing process. Read…

August 18, 2015

TOYOPEARL® NH2-750F: Aggregate Removal from Monoclonal Antibodies

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Given the current drive to reduce the cost of manufacturing for biological therapeutics, it is incumbent upon chromatographers and process engineers to streamline the manufacturing process wherever possible. As a result of this need, the demands on downstream unit operations have increased to the point where a single processing step is expected to accomplish a multitude of purification objectives. Introduction Anion exchange chromatography is a widely used technique for protein capture or impurity removal. Typically, anion exchange resins with quaternary…

August 15, 2014

Purification of Oligonucleotides on TOYOPEARL GigaCap® Q-650S

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TOYOPEARL GigaCap Q-650S high capacity, high resolution anion-exchange resin for process scale applications was recently introduced by Tosoh Corporation. This resin, with dynamic binding capacities (DBCs) approaching 190 g/L for bovine serum albumin (BSA), is the newest member of the TOYOPEARL® product line. TOYOPEARL GigaCap Q-650S maintains the high capacity of our popular TOYOPEARL GigaCap Q-650M, and the 35 µm particle size provides high resolution for improved separation of process impurities and aggregates. Introduction The purification of oligonucleotides using anion…

August 1, 2013