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The in-PharmaTechnologist Anti-counterfeiting Forum - William Reed Business Media

18-Mar-2015 - Drug counterfeiting: a pharmaceutical industry problemCounterfeiters rely on two things: poorly secured pharmaceutical supply chains; and the fact people want to pay less for less for drugs.Most fake erectile dysfunction drugs seized in Europe contain at least some trace of...
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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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A Method to Meet the New Ph Eur Ninhydrin-Positive Substances Requirement - Butterworth

27-Jan-2015 - The European Pharmacopeia (Ph Eur) is moving away from the historical thin layer chromatography technique for the determination of Ninhydrin-positive substances, to more specific and sensitive methods utilising Liquid Chromatography (LC) or Amino Acid Analysers. This paper will explore the...
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Considerations When Performing an Intact Mass Analysis of a Monoclonal Antibody by LC-MS - Reading Scientific Services Limited

23-Oct-2014 - Monoclonal antibodies are one of the most common types of biopharmaceuticals. Knowledge of an antibody’s molecular weight is essential; if this differs from predicted weight then this indicates that there is a change to the structure. One way of screening...
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5-step guide to Temp-control using passive systems - World Courier

20-Oct-2014 - Maintaining the strict temperature parameters required to ensure product stability is relatively straightforward in the plant or laboratory setting, where product remains in a stationary location, where equipment is suitably calibrated and qualified and where personnel are trained accordingly. What...
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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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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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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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Industry leading titers of protein in E.coli - Fujifilm

26-May-2014 - The development of large scale E. coli expression systems can be rate limiting in process development.  Fujifilm's pAVEway™ system combines innovative vector technology with platform fermentation processes to rapidly delivers industry leading titers.
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Elemental Impurity Analysis in Pharmaceuticals - Butterworth

06-May-2014 - A method to identify the presence of heavy metals in pharmaceuticals was introduced in the United States Pharmacopoeia more than 100 years ago. Today pharmaceutical companies are still using essentially the same method, the USP <231> Heavy Metals Limit Test....
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The Promise and Challenge of Adaptive Design: Oncology Trials - Medpace

05-May-2014 - Incorporating adaptive design methodologies into clinical trials can reduce costs while maintaining trial integrity.  Learn how these design strategies can improve the effectiveness and efficiency of oncology studies
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Meeting the challenges of complex drug substances - Vetter Pharma International GmbH

15-Apr-2014 - Realizing the full potential of an injectable drug compound is no small task. In the months and years that lead from the discovery phase to the rigorous demands of a commercial launch, unexpected scientific and technical challenges can slow development...
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Preparation of Pharmaceutical Samples for Metals Analysis -

28-Nov-2013 - With proposed changes to elemental impurities requirements for pharmaceutical products currently being reviewed, spectroscopic techniques for metals analysis are being widely discussed. The preparation of the samples is often overlooked,  this is a  critical step in producing good quality analytical...
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05-Nov-2013 - The USP is continuing to modify a proposal for using inductively coupled plasma (ICP) and ICP-mass spectroscopy (ICP-MS) to detect contaminating heavy metals in drug products. The new USP <233> describes testing methods to detect elements of interest specifically, accurately...
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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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Nucleic Acid Amplification Technique for Biosafety - SGS Life Science Services

23-Sep-2013 - Use of cutting-edge NATs reduces the amount of time needed for development and safety testing of novel biotech products. This white paper describes specific NAT applications including the detection of contaminating viruses, mycoplasma & mycobacteria.
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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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