DOWNSTREAM PROCESSING FEATURED ARTICLES
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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Phenex Enters Into A Research Collaboration And License Agreement With Janssen For Autoimmune And Chronic Inflammatory Disorders
Phenex Pharmaceuticals AG (Phenex) today announced it has entered into an agreement with Janssen Biotech, Inc. and its affiliates (Janssen) to jointly discover compounds that target the nuclear hormone receptor RORγT and may have utility in the treatment of chronic autoimmune and inflammatory disorders including rheumatoid arthritis, psoriasis, and inflammatory bowel disease.
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Avid Bioservices Announces Completion Of Facility Upgrades In Response To Increased Demand For Its Contract Manufacturing Services
Avid Bioservices, Inc, a contract manufacturing organization (CMO) focused on the process development and manufacturing of monoclonal antibodies, proteins and enzymes, today announced that its demand for services has reached an all-time high, while projected revenue for its current fiscal year ending April 2013 is expected to surpass $18 million, a 20% increase from the previous fiscal year.
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Biosensors & Big Data: Implications For Biologics Developers
Dr. Caroline Loew’s company, Glympse Bio, develops injectable, tunable biosensors that she says will help biologics developers test and measure disease progression in vivo, enabling valuable, early visibility into therapeutic efficacy.
DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES
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Optimized Purity And Recovery Of A Monoclonal Antibody Using Mixed-Mode Chromatography Media
Monoclonal 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).
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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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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
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White Paper: Computrac® Moisture Analysis Made Simple When people aren’t feeling their best they often turn to medicine for relief from the symptoms that are associated with being ill. The public trusts that the products by pharmaceutical companies will not only make them feel better but will also not have harmful side effects.
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Sani-Tech® Ultra White Paper
For several years, pharmaceutical manufacturing professionals have increasingly stated concerns about material leachables and extractables and their impact on the products they produce. Fluid transfer systems that include flexible tubing have been at the forefront of this discussion.
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Comparing The Automated Pipetting To Volumetric Glassware And Air Displacement Pipettes
Analytical sample preparation is used in many industries such as forensics, environmental chemistry, mining, beer and wine fermentation and many others. Concentrated samples are diluted and analyzed via High Performance Liquid Chromatography, Gas Chromatography, Atomic Absorption, and/or Inductively Coupled Plasma Spectroscopy to name a few. Traditionally these samples are prepared using volumetric glassware, syringes and/or pipettes.