Separation/Purification

Purification of Hepatitis B Virus Surface Antigen for Vaccine Products: Impact of Ligand Density on HBsAg Purification By Immunoaffinity Chromatography

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According to the World Health Organization (WHO), more than 350 million people worldwide are chronic carriers of hepatitis B virus (HBV) (1). Around 25% of carriers develop liver cirrhosis and/or carcinoma, making HBV responsible for the deaths of one million people annually (1). The virus has a spherical shape with a lipoprotein coating mostly of HBV surface antigen (HBsAg) (2). Knowing that, drug developers have created recombinant HBV vaccines based on HBsAg synthesized in yeast or mammalian cells (3, 4).…

Production and Purification of Newcastle Disease Virus: A High-Yield Platform Process Based on a Novel Avian Cell Line and Monolith Chromatography

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Newcastle disease is an extremely infectious condition among domesticated poultry and other avian species. Its high morbidity and mortality rates among infected birds give the disease significant economic importance. Thus, many commercially available vaccines based on live or inactivated virions are used globally to protect against Newcastle disease infection. The causative agent is Newcastle disease virus (NDV), which belongs to the Paramyxoviridae family. NDV is a single-stranded, negative-sense, enveloped RNA virus of avian origin that is highly attenuated in humans…

February 9, 2023

Opportunities in the Field of Host Cell Proteins — Part 4: The Future of Immunogenicity Prediction

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Available literature abounds with case studies describing detection and identification of host cell proteins (HCPs) and other process-related impurities. In the previous installment of our review, we analyzed noteworthy studies, highlighting what they revealed about HCP immunogenicity and calling attention to topics that require further investigation. In this final installment of our four-part study, we focus on HCP risk assessment. We explore current and emerging strategies for immunogenicity prediction, then draw out key insights from the past 40 years of…

February 9, 2023

Purity by Design

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After launching Nereus LentiHERO, a game changing fit-for-purpose solution for lentiviral vector purification in 2022, Astrea Bioseparations present this end of year report with a selection of interviews, application notes, and articles. Identifying the gaps in lentiviral purification, they discuss how to increase processing efficiency, purity, and recovery of LVV particles. They also look towards the future to bring a radical change in bioprocessing for cell and gene therapies. The Nereus LentiHERO spin column is the first product in a…

December 8, 2022

Opportunities in the Field of Host Cell Proteins Part 3: Case Studies in Impurity Detection and Identification

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Rigorous physicochemical and bioanalytical methods must be performed on biological products to ensure that they contain minimal levels of host cell proteins (HCPs) and other process-related impurities. In the first and second parts of our article, we surveyed literature about HCPs of concern, the mechanisms behind their immunogenicity, and ultimately, their consequences for patient safety. Herein, we highlight published case studies to explore difficulties with detecting, identifying, and quantifying such impurities. These examples demonstrate that much remains to be learned…

December 6, 2022

Opportunities in the Field of Host Cell Proteins: Part 2: Ensuring Patient Safety

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Process-related impurities such as host cell proteins (HCPs) can raise concerns about biological product efficacy, quality, safety depending on their properties and levels. In the first part of this series, we surveyed relevant regulatory frameworks and detailed potential effects of HCPs on biologic efficacy. Here in part 2, we review available literature on HCPs and patient safety, including information about HCP-related immune responses and adverse clinical events. HCP Effects on Patient Safety At least five HCP-induced factors can influence a…

October 20, 2022

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

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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…

October 20, 2022

Development of a Stand-Alone Monitoring Application for Purification Processes in Biomanufacturing

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The ability to monitor unit operations in biomanufacturing is essential because it enables early fault detection and effective root-cause analysis. Below, we present a case study on the development of a stand-alone, data-driven, process-monitoring application for a biomanufacturing purification process. We review the application’s functionality and highlight its utility using a few examples from commercial manufacturing of a therapeutic protein. Lessons learned from the development of that application also are presented. The progress and performance of a purification process have…

September 28, 2022

Empowering the Next Revolution

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Over the past 20 years, the bioprocessing landscape has undergone multiple transformations. Some of those were driven by biological innovations as new therapeutic platforms and modalities were introduced; others were driven by advancements in engineering and applied technologies such as single-use solutions, automation, and artificial intelligence. But the industry’s mission of making life-saving medicines that are effective, safe, and affordable remains the same. It’s rewarding to work in a field that aims to improve people’s health and life expectancies and…

August 22, 2022

Concentration and Purification of Infectious Viruses

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Throughout evolution, viruses have developed mechanisms to interact with and manipulate the genetic material of their target cells. As a result, modern virology uses a growing number of applications to understand these agents of disease. Such applications range from transfection of cells for genetic manipulation to medical studies with a strategic focus on developing novel vaccines, treatments, and gene therapies. Assessment of virus type and content is also important for ensuring food and drinking water safety as well as for…

August 16, 2022