DOWNSTREAM PROCESSING FEATURED ARTICLES
Making The Switch To Single-Use: Have You Thought Of Everything?
In 2014, Prolong Pharmaceuticals followed through with a decision to build a facility for the scale-up of their lead product, SANGUINATE. As part of this decision, the new facility would not utilize Prolong’s traditional manufacturing process and would instead switch to one that uses single-use technology (SUT) almost exclusively. Chuck Hart, Prolong’s director of manufacturing, recently sat down with me to discuss some areas he feels are sometimes overlooked when switching from traditional stainless steel to SUT.
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NIH Scientists Map First Steps In Flu Antibody Development
National Institutes of Health scientists have identified how a kind of immature immune cell responds to a part of influenza virus and have traced the path those cells take to generate antibodies that can neutralize a wide range of influenza virus strains. Study researchers from the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, were led by Gary Nabel, M.D., Ph.D., director of NIAID's Vaccine Research Center. Their findings appear online in advance of print in Nature.
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![3 Critical Considerations For Cell Therapy Manufacturing]( "3 Critical Considerations For Cell Therapy Manufacturing")
3 Critical Considerations For Cell Therapy ManufacturingWhile autologous cell therapies offer promise in the way of patient treatment, manufacturing them is a complex process requiring thorough understanding of the cell type(s) that a company will be providing as therapy. When it comes to ensuring the successful manufacturing of a cell therapy drug, Ross Tubo, chief scientific officer at Vericel Corporation, says there are three critical areas where particular attention should be paid.
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Single-Use Standardization: Is It Holding Back The Biopharma Industry?
The data from BioPlan Associates’ 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production speaks to the industry’s ongoing desires for standardization in single-use devices. As usage of these disposable devices increases, the gap between the importance of standardization and end-users’ satisfaction with their supplier’s standardization efforts has steadily been worsening.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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![Bio-rad]( "Mammalian Virus Purification Using Ceramic Hydroxyapatite")
Mammalian Virus Purification Using Ceramic HydroxyapatiteConventional techniques for mammalian virus purification produce variable quality, quantity, and significant loss of particle infectivity. We propose the chromatographic separation of viral particles of diverse sizes and from different families such as dengue, influenza, mouse hepatitis, adenovirus, poliovirus using CHT Ceramic Hydroxyapatite resin.
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![FiT_MaxiCaps-_20158]( "Accelerating Biopharmaceutical Development From DNA To Drug")
Accelerating Biopharmaceutical Development From DNA To DrugIn the last decade, single-use solutions for virtually every bioprocess unit have been developed, and considerable investments have been made by the industry into areas that underpin this technology.
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Met One Sensors Resistant To Vaporous Hydrogen Peroxide (VHP) Pharmaceutical manufacturers often require an aseptic production environment to minimize the presence of microbes and their potential contamination of the manufactured product.
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![A Purification Strategy For Clinical-Grade Monoclonal Antibody]( "A Purification Strategy For Clinical-Grade Monoclonal Antibody")
A Purification Strategy For Clinical-Grade Monoclonal AntibodymAbs are currently the most important class of therapeutic proteins. Advances in upstream process technologies have led to tremendous improvement of mAb titers in mammalian cell culture.
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Comparison Of Five Cell Culture Media Demonstrating CHO Cell Culture Growth In Batch Or Fed-Batch Process For Commercial Operations
This case study details a two month, four phase project to design chemically-defined feed media that improved two simulated batch processes utilizing products by SAFC, Life Technologies, Thermo Fisher Scientific, and Irvine Scientific. By Mark C. Arjona, Evan R. Horowitz, Alex A. Jurisch, Jenny Y. Bang, Tom Fletcher, Irvine Scientific
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![XDR-50MO]( "Microbial Fermentation In Single-Use Xcellerex™ XDR-50 MO Fermentor System")
Microbial Fermentation In Single-Use Xcellerex™ XDR-50 MO Fermentor SystemThis application note describes the performance of a single-use Xcellerex XDR-50 bioreactor system when used in cultivations of E. coli and of modified Pseudomonas fluorecsens (P. fluorescens) producing a monoclonal antibody (MAb). Both the achieved microbe densities and product yield were shown to be consistent with the performance of conventional stainless steel systems.
DOWNSTREAM PROCESSING PRODUCTS
ILC Dover brings a unique history and skill set to the biopharmaceutical industry, particularly single use biopharmaceutical powder handling and containment equipment.
Macro-Prep hydrophobic interaction chromatography (HIC) media are methacrylate-based, 50 µm beads used for protein, polypeptide, enzyme, and nucleic acid purification.
DOWNSTREAM PROCESSING MULTIMEDIA
Bioprocess With The Bozenhardts is back, with a fresh episode packed with advice from Herman and Erich on the selection of filling systems for biopharmas. Listen in as the Bozenhardts give us an update on the process, logistics, and administration trends that are informing filling system decisions today, and offer direction on making choices that will prepare you for the fast-advancing therapies of tomorrow.
Bio-Rad now offers two very high capacity ion exchangers: Nuvia S, which can be used for capture and/or intermediate polishing; and Nuvia Q, which can be used for intermediate and/or final polishing.