2018

Rapid Generation of High-Producing Clonal Cell Lines: Using FRET-Based Microfluidic Screening for Analysis, Sorting, Imaging, and Dispensing

Sales of monoclonal antibodies (MAbs) are predicted to be over US$125 billion by 2020 (1). Such revenue potential puts significant pressure on the biopharmaceutical industry to reduce timelines, especially to first-in-human trials. Cell-line development represents a large and critical portion of the early development timeline. Whether a developer is using random or targeted integration for introducing genes into a host-cell genome, the regulatory requirement for addressing monoclonality introduces a time and resource-intensive step in this process. Many different techniques are…

eBook: Scalable Cell-Based Immunotherapy Manufacture: A Comparison of Single-Use Agitated and Static Expansion Technologies

Early clinical results indicate that personalized autologous immunotherapies could revolutionize cancer treatment (1). However, challenges lie in the realization of cost-driven, scalable cell therapy (CT) manufacturing strategies (2) for generating sufficient therapies to treat a populace, thereby limiting their translation to public health (3). Primary challenges involve complex needle-to-needle logistics, complexities in closed processing, and high variability in starting cell materials that define the autologous nature of such therapies. Despite barriers in industrial-scale manufacture, public health management already has engaged…

September 2018 BioProcess Insider

Launched in June 2018, the BioProcess Insider digital information portal delivers the latest financial and business news and expert insider views influencing the commercialization of biopharmaceuticals. Here are just a few recent stories edited for our space limitations in print. For more discussion and in-depth analysis, check out the website at www.bioprocessinsider.com. Every edition provides expert and insider perspectives on current financial movements and deal-making; the newest technology purchases and capacity investments; regulations affecting the bioprocessing sector; global market actions…

September 2018 From the Editor

Magazine editors live in a strange warped time frame. We put the finishing touches on this very September issue in mid-August, having begun working with the materials a month before that. Meanwhile, we’re in talks with authors and companies who will be contributing to the pages of our October and November–December issues and inserts. Anne is working already to acquire manuscripts for the early issues of 2019. When it comes to eBooks, however, we actually put them together during the…

Dye Ingress Methods for Container–Closure Integrity Testing: An Industry Position Paper

The primary goal of container–closure integrity (CCI) is to maintain the sterility and product quality of parenteral biopharmaceuticals throughout their shelf life and use. Guidelines detailing the initial CCI qualification and validation requirements have been defined and can be found in the US Pharmacopeia chapter 1207 (USP<1207>) (1). The guidelines described in USP<1207> can be applied to any common CCI testing (CCIT) method to achieve a method suited for its intended use within a drug product lifecycle. CCI is not…

Worldwide Biopharmaceutical Manufacturing Capacity Analysis: Growth Continues Across the Board

While the growth in biopharmaceutical manufacturing capacity in developed, major market countries is continuing its slow and steady climb, developing regions often are seeing double that growth rate. Over the past eight years, as detailed in the “About the Data” box, our company’s index of the top 1,000 biomanufacturing facilities (1) has tracked and ranked bioprocessing facilities worldwide in terms of known or estimated bioprocessing capacity (cumulative onsite bioreactor volume) number of biological products manufactured at clinical scale commercial scale…

Big Biotech Data: Implementing Large-Scale Data Processing and Analysis for Bioprocessing

Managing large amounts of data presents biopharmaceutical companies of all sizes with the need to adopt more efficient ways to handle the ongoing influx of information. At KNect365’s September 2017 Cell and Gene Therapy conference in Boston, Lisa Graham (founder and chief executive officer of Alkemy Innovation, Inc. in Bend, OR) spoke about the need for data management, data analysis, and process monitoring systems to evolve. Although she was speaking at a cell therapy event, her points are applicable to…

Cell-Culture–Based Influenza Vaccine Manufacturing: Evaluation of Near-Infrared Spectroscopy for In-Line Determination of Virus Titers

Each year, over 20% of the human population is infected with the influenza virus, resulting in 250,000–500,000 related deaths globally and ~38,000 deaths in the United States alone. Of further concern is the potential for pandemic outbreaks, which pose a severe worldwide threat to public health (1, 2). Vaccination has proven to be a critical tool for controlling the spread of infectious diseases, as evidenced by the eradication of polio, smallpox, and diphtheria in most parts of the world. Influenza…

Virus Segregation During Purification Processes: Calculation of Critical Potential Carryover of Viruses

Before a pharmaceutical product is introduced into humans, either in a clinical trial or as a marketed product, virus safety must be evaluated carefully. Virus safety normally is ensured using a three step complementary approach: selecting and testing cell lines and/or raw materials for the absence of viruses, testing the product at appropriate steps of production, and assessing the capacity of a production process to clear infectious viruses (1). The latter (also referred to as viral clearance) is the subject herein. Spiking studies are conducted to evaluate the capacity of a purification…

A UF–DF Screening System for Bioprocess Development: Efficient and Cost-Effective Process Fit and Scale-Up to Manufacturing

Ultrafiltration and diafiltration (UF–DF) of therapeutic proteins are performed in either tangential or crossflow mode using membrane filters. UF–DF plays a critical role in both downstream and upstream processes for the biopharmaceutical industry (1). In upstream production processes, classical tangential-flow filtration (TFF) or alternating tangential-flow (ATF) systems are used in high–cell-density perfusion for protein expression by cell culture (2). TFF is used in downstream processing for UF–DF and concentration of therapeutic proteins. TFF unit operations are common in protein purification…