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Global Ethics - what you need to ensure integrity - World Courier

16-Mar-2015 - In a recent World Courier survey, 35% of respondents said that they were aware of bribery in their industries. This may have been acceptable in the past but now ethics, honesty, integrity and the ability to document and demonstrate them...
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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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Meaningful Metrics – A CMO Perspective - Patheon Inc

05-Jan-2015 - Learn about the roles of sponsors and their contract manufacturing organization (CMO) partners regarding metrics, what metrics to measure, how to manage data, effective communications and ownership, and ways to improve your metrics. To optimize the value of metrics, it...
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Customized drug application kits - B. Braun Melsungen AG

02-Oct-2014 - To avoid medication errors, application sets become more and more important for the pharmaceutical industry. These sets help to guarantee a safe and exact drug application.B. Braun OEM offers a flexible tailor-made solution to market your products in a ready-to-use...
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Turning “Oh No” into “No Problem” - World Courier

15-Sep-2014 - With all that’s going on in the world right now it’s vital for us all to have plans in place to deal with the unexpected. We need to be prepared individually, corporately and on a local and global level to...
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Getting more value out of your partnership with a CMO - Hospira inc

20-Aug-2014 - In the article, published in the Strategic Alliance Magazine, one of the leading injectable product CMOs takes a unique stand on managing customer relationships. The article explains how principles of Alliance Management, which has found a wide application in building...
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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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A year on, EU GDP’s affect on European Pharma Distribution - World Courier

24-Mar-2014 - World Courier welcomed the EU GDP guidelines, which created a yardstick by which logistics providers could be measured and compared.  A year on from the draft publication it is now fully in force and there has already been an update...
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17-Mar-2014 - Recipharm already has experience in serialised production. From our UK facility in Manchester over 40 batches have been delivered from a fully validated line to the Turkish market since 2010.Serialisation is a complex area and the requirements are likely to...
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Ensuring cold chain remains cold and controlled room temp remains controlled! - World Courier

24-Feb-2014 - The first of ten new vehicles have been delivered to World Courier Ground Europe, and in line with the requirements of the regulations for pharmaceutical distribution have undergone qualification testing for frozen, refrigerated and controlled room temperature conditions at extreme...
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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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(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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Pharmaceutical Development for ADCs - Baxter

05-Aug-2013 - Formulation, process, and analytical development for ADCs is complex. While an aqueous solution formulation may be preferred over a lyophilized product, it is useful to initially pursue a dual path and develop drug product formulations for both a sterile solution...
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Avoid Angry Customers-Eliminate Defects - METTLER TOLEDO

12-Jun-2013 - In the pharmaceutical business, it is crucial that containers be free of contamination, formation defects and dimensional irregularities to avoid the risk of product contamination. As a result, pharmaceutical companies must have strict quality standards and robust inspection programs. Vision...
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Supply Chain Issues and Trends in Asia - Marken

02-May-2013 - Import/export of biological samples from China China: Large Pharma Reverse Logistics A Common Issue: Destruction of Drug in Taiwan J-GMP: How is GMP different in Japan? Korea: Biosimilars Hotbed India: Will Regulations Change to Allow Quicker Study Approval in 2013?
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Blinding Techniques for Inhaler Devices - Development of a Novel Blinding Methodology for a Market Leading DPI - Almac Group

21-Jan-2013 - Blinding inhalers for use in clinical studies is a challenging and specialised area of clinical trial supplies. In this case study, Almac provide a real life overview of their unique inhaler blinding services which have been successfully developed and validated,...
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Alkermes’ successful approach to commercial scale final dosage manufacture of drug product containing highly potent API - Alkermes

18-Dec-2012 - With 45 years’ in the service business, Alkermes Contract Pharma Services, has proven expertise in drug process design  improvements, tech transfer and commercial scale cGMP manufacturing of oral and injectable dosage forms, including the handling of highly potent drug substances.This...
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Lyophilized Pharmaceuticals: A Design Space Approach - Baxter

29-Oct-2012 - This presentation by Steven Nail, PhD and principal Scientist for Baxter BioPharma Solutions, discusses development of design spaces for lyophilized pharmaceutical products in the context of the Quality by Design regulatory paradigm.
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TLM Pharma – Packaging Line for Vials - Schott Relations GMBH

11-Jun-2012 - A Russian customer is currently packing 20 different packages on his new TLM pharma-machine. They are packed with various vials in packaging boxes with differing content.

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