Author Archives: Patrick Endres

Two-Step Monoclonal Antibody Purification Using a Multicolumn Continuous Chromatography Platform

Biomanufacturers typically have relied on multistep processes for optimal removal of impurities such as host-cell proteins (HCPs), DNA, adventitious viruses, and aggregates. However, additional purification steps increase downstream expenses significantly, including costs of supplementary resin, hardware, and buffers. The substantial footprint required at a processing site and additional time needed to perform a complete multistep purification process also increase production costs and complicate process execution. Thus, it is imperative to design and test effective purification procedures for high-quality biotherapeutics, but…

Development of a Universal Preparative Anion-Exchange Method to Purify Oligonucleotides

Oligonucleotide-based therapeutics have been studied over recent decades, and their promise as a new drug modality is now being realized. The growing interest in oligonucleotides is driven by their high potential for treating different medical conditions, the growing number of oligonucleotide drugs approved by the US Food and Drug Administration (FDA), an increased focus on personalized medicines, the development of therapies for rare diseases, and the wide adoption of nucleotide-based COVID-19 vaccines. Oligonucleotides are short, linear sequences of DNA or…

Reduce Downstream Processing Costs for Monoclonal Antibodies: Switch to Tosoh’s Two-Step Platform

In this study, we showcase the benefits of Tosoh’s two-step process for the purification of monoclonal antibodies (MAbs) in comparison with the standard industrial process. Combining high-performance protein A capturing and a single polishing step on a salt-tolerant anion-exchange resin, we could reduce the downstream costs by 45% and increase production output by 58%. TOYOPEARL AF-rProtein A HC-650F is a high-capacity protein A resin for the purification of MAbs. This resin exhibits dynamic binding capacities (DBC) of 70 g/L at…

Reduce Downstream Processing Costs for MAbs By Switching to a Two-Step Platform

Downstream processing operations make up to 80% of the total costs for processing biotherapeutics. Given the current drive to reduce downstream costs, chromatographers and process engineers will need to streamline processes. Herein, we describe the benefits offered by using Tosoh’s two-step process for purifying monoclonal antibodies (MAbs) and compare that method with the standard industrial process. By combining high-performance protein A capture and a single polishing step on salt-tolerant anion-exchange resin, Tosoh’s approach can reduce downstream costs by 45% and…

Tosoh LenS3™ MALS Detector: A New Paradigm in Light-Scattering Technology

The multi-angle light scattering (MALS) technique has become the standard for determining molecular weight (MW) and size (radius of gyration, Rg) of proteins, biopolymers, synthetic polymers, and polysaccharides. By combining an extreme low angle (low-angle light scattering (LALS) – 10°) and an extreme high angle (high-angle light scattering (HALS) – 170°) with a right angle (right-angle light scattering (RALS) – 90°) to form a three-angle MALS detector, the new LenS3 detector can determine directly absolute molecular weight and Rg without…

Antibody–Drug Conjugate Surrogate Purification: TOYOPEARL® PPG-600M HIC Resin for DAR-Separation

Antibody–drug conjugates (ADCs) are promising biopharmaceuticals. They combine the high selectivity and affinity to cancer cells with the toxicity of chemotherapeutics in one molecule. ADCs consist of a monoclonal antibody covalently bound by a linker to a highly potent cytotoxic drug. ADC-surrogates contain a nontoxic payload with similar structure and physiochemical properties as the toxic payload of an ADC. Therefore, they can be used as models to develop suitable purification processes or analytical methods. The ADC-surrogate in this work consists…