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The whole blood assay: Detection of broad spectrum of pyrogens & examples of medical device testing - Merck Millipore microbial industry

09-Mar-2015 - Pyrogens in pharmaceuticals, medical devices, biotherapeutics and cosmetics can cause fevers in humans and are potentially life-threatening. Yet standard pyrogen detection methods have drawbacks. The Limulus Amoebocyte Lysate (LAL) test only identifies endotoxins, while the rabbit pyrogen test (RPT) endangers...
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Temperature-Controlled IMP Distribution Challenges - Almac Group

04-Aug-2014 - UNDERSTANDING THE CHALLENGES OF TEMPERATURE CONTROLLED INVESTIGATIONAL MEDICINAL PRODUCT DISTRIBUTION IN EMERGING MARKETSTemperature deviation within the supply chain is a complex issue. While the risk of shipments going outside their specifications may never be completely eliminated, it can be minimized...
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Learn the risk factors of metabolic syndrome and the role central labs play in aiding its detection - ACM Global Central Laboratory

17-Jun-2014 - Metabolic syndrome, a serious condition impacting adults and children in all genders, races and ethnicities, can lead to fatal outcomes if not detected and treated. The key risk factors of metabolic syndrome were identified approximately 250 years ago. However, there...
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Fast and Flexible – Early Phase Manufacturing - Patheon Inc

05-May-2014 - Early-stage manufacturers of oral solid dosage forms need to be fast and flexible to generate development pathways that can cope with variable API characteristics as well as highly potent molecules. Technology, risk assessment, Quality by Design and scale up are...
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Orthotopic Brain Tumor Models Improved with Imaging - Molecular Imaging Inc.

14-Apr-2014 - Know more: enhance in vivo pharmacology with imaging. Recent tumor model development and informative imaging technologies have enabled the efficient and robust use of orthotopic models. These models have proven to be the most clinically relevant and predictive cancer models....
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Footprint-Free™ Cell Line Engineering Services at Transposagen -

13-Feb-2014 - Altering the genome of cells is a powerful and increasingly necessary tool for drug discovery and research. Transposagen utilizes its expertise and a diverse portfolio of gene editing tools including XTN™ TALENs, CRISPR nickases, as well as piggyBac™ transposons, for...
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Controlled Release and Bioavailability Enhancement -

28-Oct-2013 - Metrics provides product development that leverages proprietary pharmaceutical technologies in the areas of: •    Customized Controlled Release Drug Delivery •    Bioavailability Enhancement •    Taste Masking (liquid and solid presentations)When applied appropriately, these technologies can deliver therapeutic and convenience benefits to...
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New Guidelines for Stabilization of Proteins by Freeze Drying: Formulation and Process Heresy - Baxter

17-Oct-2013 - Over the years a number of informal guidelines or “rules” for the formulation and processing of proteins for freeze-drying have been developed. However, in recent years it has become obvious that some of these rules need modification. In this presentation,...
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Biosimilars – Landmark Developments Point to the Future for Regulations and Analysis - SGS Life Science Services

30-Aug-2013 - 2013 is a landmark year for biosimilars, with the approval of the first biosimilar mAb and regulatory developments across the globe. Correctly interpreting the analytical requirements in these regulations is critical to demonstrate Biosimilarity. This webinar will review the evolution of...
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(b)(2) or not (b)(2)? That is the question. - Camargo

19-Aug-2013 - 505(b)(2) is more than a regulatory pathway - for many, it’s a unique strategy that can often result in product approval with lower risk, reduced development cost and faster speed to market. So, is (b)(2) for you? To find out...
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Antibody Drug Conjugate Development and Manufacture - Piramal

03-May-2013 - With the recent approvals of brentuximab vedotin (Adcetris) and ado-trastuzumab emtansine (Kadcyla,T-DM1), antibody–drug conjugates (ADCs)are a rapidly growing area in oncology with great potential. Development and manufacture of ADCs can be a challenge with the requirement to handle both biologics...
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ePathology Improves Data Accuracy & Study Productivity! – Amicus Study Confirms - Aperio

20-Mar-2013 - With current glass slide methods, sharing and scoring slides within a study from one pathologist to another at a different organization or site, meant that slides had to be packed, shipped and tracked. Often the reading pathologist was required to...
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Quantify biodistribution, enhance in vivo decisions - Molecular Imaging Inc.

04-Feb-2013 - Non-invasive preclinical SPECT imaging of test agent biodistribution, kinetics and targeting in discovery and safety applications has key advantages over pre-existing methods including: full 3-dimensionality with tissue and sub-tissue localization fine kinetics, targeting, binding and clearance pathways can be examined clinical translatability isotope multiplexing...
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Biomarkers of Toxicity Panel in Clinical Trials - ACM Global Central Laboratory

18-Sep-2012 - Most drug candidates are discontinued because of induced organ toxicity and half of them owe this to liver toxicity. This issue explains why drug developers need to be aware of the latest options for liver and kidney laboratory safety testing,...
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Utility of FDG PET in Drug Development - Molecular Imaging Inc.

20-Aug-2012 - Imaging metabolism with FDG PET offers reliable and clinically translatable biomarkers for evaluation of candidate compounds.
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Novel Biomarkers for Diabetic Nephropathy - Pacific Biomarkers, Inc.

18-May-2011 - Type 2 diabetes is the major cause of end-stage renal disease. In the present decade, 30% of the predicted $1.1 trillion medical costs of dialysis world-wide will result from diabetic nephropathy. There is an unmet need for highly sensitive biomarkers...
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Guiding Development of Novel Drugs - PBI

16-Mar-2011 - Increased use of therapeutic proteins such as monoclonal antibodies, engineered proteins and other biological products has resulted in a growing number of biotherapeutic drugs. New biotherapeutic drugs bring tremendous advancement in the treatment of a number of diseases. To ensure...
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Biomarkers of Metabolic Syndrome in Clinical Trials - PBI

11-Feb-2011 - PBI scientists will discuss latest developments in biomarkers for metabolic syndrome. Topics: 1) Pre-analytical and analytical concerns regarding gut and incretin hormones, 2) Dysfunctional HDL biomarkers in metabolic syndrome, and 3) Kidney Injury Markers and their usefulness in diabetic nephropathy....
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Reducing Dosing Errors in Preclinical GLP Infusions - Solomon Scientific

09-Feb-2011 - The White Paper explains that the Orchesta™ Automated Infusion System from Solomon Scientific reduces dosing error opportunities by 99% in preclinical GLP infusion studies. The system is validated for GLP and Part 11 compatibility. A typical preclinical GLP infusion study...
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Incretins & gastrointestinal hormones - PBI

26-Jan-2011 - The digestion and absorption of nutrients subsequent to food intake is associated with increased secretion of multiple gastrointestinal (GI) peptides. Testing for incretins, and other GI hormones, presents numerous challenges because of their instability. The degradation and modification of gut...

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