DOWNSTREAM PROCESSING FEATURED ARTICLES
Recently, the U.S. Food and Drug Administration issued a proposal designed to assist companies developing new treatments for patients in the early stages of Alzheimer’s disease, before the onset of noticeable (overt) dementia.
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Flu Shot During Pregnancy Shows Unexpected Benefits In Large Study
Getting a flu shot during pregnancy provides unanticipated benefits to the baby, according to the authors of a large population-based study examining the issue.
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Dr. Brad Vince Of Vince & Associates Clinical Research Announces Award Of Nearly $10M Contract From The National Institute On Drug Abuse
Vince & Associates Clinical Research announced it has been awarded a contract with the National Institute on Drug Abuse, part of the National Institutes of Health (NIH), to carry out clinical pharmacology studies to determine the pharmacokinetics and pharmacodynamics of new medication in humans.
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Avalanche Biotechnologies, Inc. And Lonza Announce Global Manufacturing Collaboration For Adeno-Associated Viral Vectors For Gene Therapy
Avalanche Biotechnologies, Inc., a leader in the area of long-term protein delivery for ocular diseases, and Lonza, a global leader in the field of biologics manufacturing, recently announced a manufacturing collaboration focused on process development and scale-up efforts for the manufacturing of adeno-associated viral (AAV) vectors for gene therapy.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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Best Practices For Process Scale Column Packing Of CHT™ Ceramic Hydroxyapatite Media
CHT ceramic hydroxyapatite media require specific considerations during process-scale chromatography packing due to high specific gravity, rapid settling rate, and sensitivity to mechanical shear.
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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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Proven Long Life Lasers™ In Optical Particle Counters Optical particle counters (OPC) utilize light illumination and extinction to determine the presence, size, number and/or concentration of particles. Particles are typically suspended in a fluid or air, which flow through the volume that is illuminated and viewed by the detection system.
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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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Quality By Design In Biomanufacturing
QbD is increasingly required in our industry, but there are still gaps in understanding how QbD applies to the biomanufacturing process.
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Microbial Fermentation In Single-Use Xcellerex™ XDR-50 MO Fermentor System
This 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.