DOWNSTREAM PROCESSING FEATURED ARTICLES
Galapagos NV (EURONEXT BRUSSELS: GLPG) announced today that it agreed with Roche to end their alliance in fibrosis.
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FDA Approves First Drug-Eluting Stent To Treat Peripheral Arterial Disease
The U.S. Food and Drug Administration approved the Zilver PTX Drug-Eluting Peripheral Stent (Zilver PTX Stent), the first drug-eluting stent indicated to re-open a particular artery in the thigh (femoropopliteal artery) when narrowed or blocked as a result of peripheral artery disease (PAD).
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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.
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GSK Receives FDA Approval For MenHibrix
GlaxoSmithKline plc announced recently that the U.S. Food and Drug Administration (FDA) has approved the vaccine MenHibrix [Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine].
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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Biomanufacturing Debottlenecking And Process Optimization
Optimizing biomanufacturing is particularly challenging because of variability and complexity associated with the sharing of finite and interdependent resources. By BIO-G
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Turning Data Into Information
As biopharmaceutical manufacturing has evolved from small-scale lab production in small flasks to massive commercial production in deep-tank bioreactors, an avalanche of production data has evolved to support it. From individual unit operation skids to distributed control systems and enterprise resource planning tools, biomanufacturing today is buried by the sheer quantity of data coming in from the manufacturing floor.
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Avoiding Drug Shortages With Microbial Detection
Over the past year, critical drug shortages used to treat a host of life-threatening illnesses have been making headlines. Microbial contamination has been cited as a major contributor to the shortage, yet the prevailing practices to ensure the safety of drugs have been slow to change. In most cases, quality assurance practices safeguarding the drug making environment continue to rely on periodic air and a culturing method from a prior century. By Aric Meares, President and CEO, BioVigilant
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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.
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Top 10 Considerations When Selecting An Isolator Supplier
While price is certainly an important reason for buying any piece of capital equipment, it is not always the top reason. There are important considerations to examine when selecting an isolator supplier.
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Guidelines For Proper Filtration And Delivery Of Samples To On-Line Process Analyzers
Increasingly precise process control strategies, often linked to computer control, have accelerated the use of sophisticated on-line chemical composition analyzers in plant applications. Instruments such as gas and liquid chromatographs, ion chromatographs, laser optic instruments, atomic absorption instruments and specific ion analyzers, which were rarities in laboratories ten years ago, are now found routinely in plant settings. By Ken Perrotta, Division Engineering Manager