Current Issue

The November issue manufacturing theme features articles on biopharmaceutical manufacturing data analysis and visualization, ADC development, antibody higher order structure stability, microchip chromatography, and using minibioreactors for microbial cultivation scale-down.

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FEATURED REPORT: Bioprocess Monitoring and Control

The need for advanced control strategies for bioprocessing and biomanufacturing is growing, and several manufacturers already have leveraged new automation and software solutions for bioprocess monitoring and control. In this Featured Report, authors discuss new approaches for process control that make use of increased computational power; advanced sensors, probes, and sampling technologies; and new software systems that can be applied to a wide range of operational modes (e.g., perfusion, continuous, and multicolumn platforms). Such technologies can be applied with single-use systems and within PAT and “machine learning” applications.

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Development of a Host-Cell Protein Platform Assay for a Chinese Hamster Ovary Cell Line

The Chinese hamster ovary (CHO) cell line is the most prevalent biopharmaceutical expression system and has been proven safe for commercial production of protein therapeutics (1). However, even after multiple purification steps, biopharmaceuticals contain residual host-cell protein (HCP) impurities that pose a potential safety risk to patients (2). Health authorities demand close monitoring of HCP impurities and require sensitive analytical methods with high coverage: the ability to detect a broad range of HCP impurities (3, 4). Polyclonal sandwich immunoassays are…


Data Analysis and Visualization to Improve Biopharmaceutical Operations Part 1: What Are You Trying To Measure?

This begins a five-article series of “how-to” guides for tackling the most common obstacles in assessing, measuring, analyzing, and improving the performance of global biopharmaceutical manufacturing operations. Each installment covers a component of proper collection, analysis, and use of data for the best possible performance outcomes. When taken as a whole, the series should provide imperative best practices for handling business-performance data. First, consider what you want to know about your bioprocesses. How can you more appropriately measure those data…

Advances in Gene Therapy: MiniTEM™ Represents a Paradigm Shift in the Characterization of Viral Vectors

Gene therapy is one of the most progressing fields in life sciences. Although only eight gene therapy products have reached market approval, the pipeline is robust with ~500 candidates in different stages of clinical development. More than 1,700 clinical studies are being conducted, and the value of this industry segment is expected to grow by ~17% annually over the next 10 years. Gene therapy involves using genetic material to fight or prevent disease. The gene is delivered into a patient’s…