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Cell Culture Media: An Active Pharmaceutical Ingredient or Ancillary Material?

by Abrar Alturkistani, Alison R. Carter, Edward Meinert and David A. Brindley

Cell-based therapies are used to treat diseases that require the replacement of diseased, dysfunctional, and injured cells (1). To produce these therapies, a wide range of reagents and materials such as antibodies, growth factors, and enzymes are used in their manufacturing processes. Such necessary materials are administered through a cell culture medium. Active pharmaceutical ingredients (APIs) are the main ingredients that make products therapeutic. Ancillary materials (AMs) and raw materials (RMs) are essential components used during production but are not…

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

by Mike Delahaye, Henrieta Fraser and Nicholas Gaddum

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…

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

by Scott Ewan, Stefanie Adler, Nicolas Coopmans, Marta Corcoran, Sean Fadden, Chris Feeney, Jason Fernandez, Henri Hebting, Olivia Henderson, Steve Klohr, Michael Koby, Josh Lance, Brian Lee, Lei Li, Doug McNeill, Roman Mathaes, Dale Moore, Jeff One, Kashyap Panya, Suzanne Pellinen, Amanda Scruggs, Kamran Simani, Mauro di Stefano, Jared Trefethan, Harold van Deinse, Brian Vanness, Amy Wang and Klaus Wuchner

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

by Ronald A. Rader and Eric S. Langer

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

by S. Anne Montgomery and Lisa J. Graham

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

by Lucas Vann and John D. Sheppard

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…

The Effect of Albumin on Viability in Stem Cell Therapy

by Phil Morton and Daniel Shelly

Stem cell therapies are some of the most cutting-edge and sophisticated therapeutic developments. They offer an attractive alternative approach to more widely used treatments for conditions such as multiple sclerosis, metabolic diseases, cardiovascular disease, liver disease, and cancer. But developers still face challenges, some of which can be addressed by the use of recombinant human albumin. As a long-established ingredient of cell culture media, albumin is well recognized for its ability to facilitate growth of many cell types. The industry is expanding its use of high-quality, fully recombinant, current good manufacturing practice…

In-Line Turbidity Sensors for Monitoring Process Streams in Continuous Countercurrent Tangential Chromatography (CCTC)

by Dmitriy Fedorenko, Jasmine Tan, Oleg Shinkazh and Dennis Annarelli

A strong connection between turbidity and total suspended solids (TSS) has been linked in the past to measuring well defined particles in processes. Optical density probes have seen wide adoption in the biotechnology industry for monitoring cell growth within a bioreactor, whereas in-line turbidity sensors have been used to monitor filter performance. Turbidity measurements offer a rapid quantification of suspended solids but have not been used in the biotechnology industry for chromatographic resins. In this study, turbidity measured with equipment developed by PendoTECH was used with novel continuous chromatography technology developed by Chromatan…

Designing Laboratories for Flexibility and Collaboration

by Roger Humphrey

The blockbuster business model may have paid off in the past, but tomorrow’s biopharmaceutical successes will depend more on rapid and diverse discovery than on any single breakthrough. In the race to get new therapies from research and development (R&D) into pharmacies, next-generation laboratory space could become a game-changer. Blockbuster drugs typically were made in industrial laboratories — and industrial-strength measures were required to reconfigure those spaces as new research priorities emerged over time. Facing changing patient needs and ongoing…

Seamless Transition from R&D to Manufacturing

by Gene W. Lee, Kristi Sarno, Joshua Speidel, Peter Latham, Angela Lim, Jessica Dawson, Kevin McCarthy, Jonathan Souquet, Hervé Broly, Matteo Costioli and Robert Huebner

Fast and cheap: These criteria are becoming ever more urgent drivers for manufacturers of biologics, faced with increased scrutiny on the costs of developing novel drugs, the lengthy timelines for delivering these drugs to patients, and the tightening competition to capitalize on new targets. The challenge for manufacturers is further heightened by the expectations to deliver on quality as well. Although development and production of molecules such as monoclonal antibodies (MAbs) have greatly benefited from the “platformization” of core technologies…