DOWNSTREAM PROCESSING FEATURED ARTICLES
OHSU Doernbecher Scientists First To Grow Liver Stem Cells In Culture, Transplant Them With Demonstrated Therapeutic Benefit
For decades scientists around the world have attempted to regenerate primary liver cells known as hepatocytes because of their numerous biomedical applications, including hepatitis research, drug metabolism and toxicity studies, as well as transplantation for cirrhosis and other chronic liver conditions.
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The Value of Closing Your Process
For R&D and PD applications, closed, single-use systems can protect against both biological and cross-contamination, saving valuable research time and money.
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Bionengineers Introduce "Bi-Fi" — The Biological Internet
If you were a bacterium, the virus M13 might seem innocuous enough. It insinuates more than it invades, setting up shop like a freeloading houseguest, not a killer. By Andrew Myers
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Roche Receives FDA Clearance For Herpes Simplex Virus Type 1 And 2 Tests
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for its IgG Antibody to herpes simplex virus (HSV) types 1 and 2 assays for use on cobas® modular platforms. The tests are intended for use with sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-1 and HSV-2 infection.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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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.
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Cultivation Of CHO Suspension Cells And SEAP Expression
This application note describes the cultivation of CHO suspension cells in the wave-mixed Thermo Scientific HyPerforma Rocker Bioreactor with a maximum working volume of 5 L.
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A Disposable Valve For Process Chromatography
This case study discusses the need for a fully automated, disposable chromatography system which was PLC controlled and designed for use in a cGMP environment. The required applications for the chromatography system included contamination removal, and concentration and purification of biologically derived proteins used in the production of research and clinical materials.
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White Paper: Comparability Of The Cell-Freeze® (Charter Medical) Freezing Bag To The Cryocyte™ (Baxter) Bag For Cryogenic Storage Of Human Hematopoietic Progenitor Cells Successful cryopreservation of hematopoietic progenitor cells (HPC) is dependent upon a number of factors, including the biopreservation media, freezing rates, and storage using sterile, cryogenically durable storage bags. The Cell-Freeze® cryogenic storage containers are 510(k) cleared for storage, preservation and transfer of hematopoietic progenitor stem cells (HPC’s). By Charter Medical, Ltd.
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Comparability Of The Cell-Freeze® (Charter Medical) Freezing Bag To The Cryocyte™ (Baxter) Bag For Cryogenic Storage Of Human Hematopoietic Progenitor Cells Successful cryopreservation of hematopoietic progenitor cells (HPC) is dependent upon a number of factors, including the biopreservation media, freezing rates, and storage using sterile, cryogenically durable storage bags. The Cell-Freeze® cryogenic storage containers are 510(k) cleared for storage, preservation and transfer of hematopoietic progenitor stem cells (HPC’s). By Charter Medical, Ltd.
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Biomanufacturing Supply Chains
This white paper examines the major issues with biopharmaceutical supply chains and how to balance inventory and risk optimally in the network.