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Alkermes’ successful approach to commercial scale final dosage manufacture of drug product containing highly potent API - Alkermes

17-Mar-2015 - 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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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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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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Process Transfer Excellence – Basis for a fast and successful project - BOEHRINGER INGELHEIM GmbH

30-Sep-2014 - This whitepaper will focus on the interaction and collaboration with externals customers when transferring processes from a customer to one of Boehringer Ingelheim’s manufacturing sites.Boehringer Ingelheim is one of the world’s leading companies for contract development and manufacturing of biopharmaceuticals....
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26-Sep-2014 - A child in Australia is critically ill and in immediate need of a drug available only in the United Kingdom. Marken’s team of experts uses its immediate access to validated packaging and airline contacts to secure a direct flight. Through...
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7 Common Myths about QP Training Debunked : A Guide for Senior Managers - Reading Scientific Services Limited

11-Sep-2014 - The role of the Qualified Person (QP) in the pharmaceutical industry is mandated by law (Directive 2001/83/EC, Directive 2001/20/EC, UK SI 2012/1916, UK SI 2004/103). Every holder of a relevant Manufacturers Authorisation (human and veterinary) must have at least one...
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Developing a Good Plan B - World Courier

01-Sep-2014 - World Courier is continuously looking out for trouble on a local and global scale.  Areas of conflict that might affect transport routes? A hurricane? A new ash cloud pending? A problem with an airline or airport? In addition to scanning...
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Analysis of Biopharmaceuticals to Conform to ICHQ6B -

24-Jul-2014 - Worldwide, the pharmaceuticals market is anticipated to grow from more than USD 782 billion in 2011 to approach a value of just over USD 971 billion by the end of 2016, registering a CAGR of over 24%.In 2010 the average...
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Orthogonal Approaches for the Analysis of Protein Sequence and Post Translational Modifications of a Monoclonal Antibody -

19-Jun-2014 - Monoclonal antibodies are an important class of biopharmaceuticals. They are expressed from living cells and therefore, are subject to complex biochemical pathways. Not all of these pathways are fully understood and many are known to be sensitive to subtle environmental...
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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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Setting the Standard for Plasmid DNA Production - BOEHRINGER INGELHEIM GmbH

06-Jun-2014 - Boehringer Ingelheim stands out due to global contract manufacturing excellence in plasmid DNA production. It is one of the world’s leading companies for contract development and manufacturing of biopharmaceuticals. Boehringer Ingelheim is a global service provider for a broad range...
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High Potency Manufacturing - Key selection criteria when evaluating an outsourcing partner - Alkermes

08-Apr-2014 - Many companies are choosing to outsource the manufacture of their highly potent compounds.  A provider of contract pharma services in high potent manufacturing, Alkermes Contract Pharma Services, outlines elements that should be considered  when outsourcing secondary processing (i.e. dosage form...
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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...
Download now!Technical / white paper

Global Disposable Concept at Boehringer Ingelheim - BOEHRINGER INGELHEIM GmbH

18-Feb-2014 - Boehringer Ingelheim is one of the world’s leading companies for contract development and manufacturing of biopharmaceuticals. We are a global service provider for a broad range of customers – from small Biotech to Big Pharma. We provide expertise, commitment and...
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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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Making a safe choice for the manufacture of hormones - Recipharm AB

14-Oct-2013 - As consumer demand for hormones increases worldwide, and formulations for manufacturing advance from microgram to milligram levels, what should you look for from a CMO to ensure quality and safety?Find out how the improvements Recipharm has made to its Ashton,...
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Exploring New Frontiers in Direct to Patient Home Delivery Services for Clinical Trials Materials - Marken

07-Aug-2013 - Exploring New Frontiers in Direct to Patient (DTP) Home Delivery Services for Clinical Trial Materials provides an in-depth look at reasons to consider a DTP solution. Included in the discussion are concerns with the traditional distribution channels, advantages and challenges...
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What Non-statisticians Need to Know about Statistics in Clinical Trials - Rho

04-Apr-2013 - Through real-world examples, webinar participants learn strategies for choosing appropriate outcome measures, methods for analysis and randomization, and sample sizes as well as tips for collecting the right data to answer your scientific questions. 
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Analytical Method Development and Validation — A CDMO Perspective - DPT Labs

28-Nov-2012 - Pharmaceutical drug product development can be an expensive and time consuming process. Many challenges are faced by pharmaceutical development companies including developing a scaleable, marketable formulation, ensuring safety and efficacy of the drug product and receiving approval of the drug...

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