DOWNSTREAM PROCESSING FEATURED ARTICLES
The U.S. Food and Drug Administration announced recently the approval of Flucelvax, the first seasonal influenza vaccine licensed in the United States produced using cultured animal cells, instead of fertilized chicken eggs. Flucelvax is approved to prevent seasonal influenza in people ages 18 years and older.
-
Thallion And LFB Terminate Shigamabs Collaboration
Thallion Pharmaceuticals Inc. (TSX-V: TLN) ("Thallion") and LFB Biotechnologies ("LFB") today announced that they have reached an agreement on the termination of their Development and Licensing Agreement related to Thallion's Shigamabs® program.
-
MorphoSys Receives First Patent On Novel Antibody Platform Ylanthia In The US
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) today announced that the US Patent and Trademark Office (USPTO) has granted the first patent covering the Company's latest antibody platform Ylanthia, which became commercially available for existing and new partners in 2012.
-
Forsyth Scientists Define The Bacteria That Live In The Mouth, Throat, And Gut
For the first time, scientists have defined the bacteria that inhabit multiple sites along the healthy human digestive tract in a large number of individuals. To prevent and control bacterial diseases, it is essential to first identify which bacteria are responsible for keeping us in good health.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
-
Managing Cell-Based Potency Assays: From Development To Lifecycle Maintenance
Characterization of a biological product — which includes the determination of physicochemical properties, biological activity, immunochemical properties, purity and impurities — is necessary to establish the safety and efficacy profile of a given product (ICH Q6B). By Dr. Weihong Wang, manager, Molecular and Cell Biology, Eurofins Lancaster Laboratories
-
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
-
Improving DNA Removal from Bioprocess Purification Processes
Many new biological drug products produced using recombinant DNA technology, such as monoclonal antibodies, are produced in cell culture. Because therapeutic proteins such as monoclonal antibodies are produced in cell culture, impurities can result from the host cells, or cell substrates. By 3M Purification Inc.
-
The Challenge of Measuring Total Organic Carbon In Modern Pharmaceutical Water Systems
Total Organic Carbon (TOC) is one of the quality attributes defined in the European and USA pharmacopoeias for pharmaceutical waters. Modern water treatment systems can deliver such high purity water that TOC levels can be consistently close to zero and very difficult to measure with any accuracy. This paper discusses some of the challenges when using TOC analysers to demonstrate pharmacopoeial TOC level compliance for modern water systems in the light of the ICH Q2 document from the International Conference on Harmonisation.
-
![Optimized Purity And Recovery Of A Monoclonal Antibody Using Mixed-Mode Chromatography Media]( "Optimized Purity And Recovery Of A Monoclonal Antibody Using Mixed-Mode Chromatography Media")
Optimized Purity And Recovery Of A Monoclonal Antibody Using Mixed-Mode Chromatography MediaMonoclonal antibodies (mAbs) remain a predominant class of therapeutic protein products on the market because of their wide range of applications in disease treatment and diagnosis. Over the years, upstream technology advancements have helped improve the titer of target antibodies, from merely 1 g/L two decades ago to 10–13 g/L in fed-batch processes and up to 25 g/L in perfusion cultures today (Gronemeyer et al. 2014).
-
Rapid Chemically-Defined Feed Media Development to Improve Simulated Cell Culture Processes
Implementing an optimized feed medium may be the most effective alternative for modifications to the growth medium in an existing process.
DOWNSTREAM PROCESSING PRODUCTS
The ReadyToProcess WAVE 25 rocker features integrated temperature sensors and load cells, designed for convenient handling and control of cell cultures up to 25 L. A filter heater is delivered with the system.
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.