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Pharmaceutical Manufacturing and Packing Sourcer

pmps
Autumn 2009
At the cutting edge of the latest industry developments, Samedan is adept at keeping the information you need at your fingertips. PMPS provides a unique platform of communication for the market across Europe, North America and the rest of the developed world. To find out what's hot in the world of pharmaceuticals, take a look below at the range of articles featured in this issue of PMPS.
   
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Drug Delivery 
Extractables and leachables represent a complex area of inhaled and nasal drug delivery but, as Andrew Feilden of AstraZeneca explains, a comprehensive knowledge of their science can help drug manufacturers to meet regulatory needs and assure patient safety.  
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There are a number of well-established medicines which utilise the nasal adminstration route, but lower manufacturing and assembly costs need to be achieved for technology in this field to take the next step, argue Ian Harrison at Alchemy Healthcare and Steve Nichols, Independent Consultant.  
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Another drug administration whose effectiveness can be increased by new developments is transdermals. Vishal Sachdeva and Ajay K Banga from the Department of Pharmaceutical Sciences, Mercer University, review the advantages and drawbacks of various options for manufacturers.  
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MANUFACTURING

Companies going through mergers are always keen to take the opportunity to maximise efficiency in their operations. Steve Hemsley at Lanner asserts that this can be achieved with the use of process simulation software, which can provide definitive guidelines for unifying fragmented business processes.

 
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Technological solutions to drive efficiency go beyond simply using the latest available software. Keith Thornhill at Siemens urges pharmaceutical manufacturers to focus on long-term strategies for streamlining processes, and points out that implementing machinery standardisation is one way of going about this.  
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Continuing the theme of increasing efficiency in drug production, Dieter Bandtel at Bosch examines the latest technological advances that have increased automation and flexibility in the drug manufacturing process.  
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Microencapsulation is a key production step, which protects active pharmaceutical ingredients against degradation, and can be performed through a variety of techniques. Marco Gil and Filipe Gaspar at Hovione focus on spray drying - one of the most efficient and robust methods of microencapsulation.  
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Cargo & Cool Chain
In the context of new regulations for air cargo carriers, pharmaceutical goods are subject to certain special conditions. Joe Reedy at American Airlines Cargo looks at how medicines differ from other freight, and what this means for those transporting pharmaceutical products across the globe.  
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Ensuring the safe transportation of temperature-sensitive pharmaceuticals is something that will benefit all stakeholders in the supply chain. Stuart Forsyth at British Airways World Cargo suggests that cooperation between all parties is the best way to achieve this.  
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The globilisation of the pharmaceutical supply chain and the increasingly stringent demands from regulatory bodies with regards to product security have led airlines to focus heavily on pharmaceutical cargo. Tony Wright of Exelsius Cold Chain management COnsultancy asks whether improvements in quality will follow.  
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Bill Hook at UPS emphasises the importance of strategic planning in well-developed cold chain operations, pointing out that forward thinking and an appreciation of the complexity of the supply chain are as important as utilising the latest technology.  
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Pharmapack 2010 supplement
Addressing the increasingly important issue of anti-counterfeiting measures in drug packaging, Eric Caro at Catalent Pharma Solutions suggests that the ideal course of action involves a combination of both covert and overt techniques.  
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Maintaining open lines of communication between IT and enterprise environments is crucial for an effective packaging strategy. Stephen Lisa at Systech International believes that this can be achieved by employing a packaging execution system.  
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Using state-of-the-art technology in the war against fake drugs is only part of the solution. Ulrike Kreysa and Jan Denecker at GS1 recommend that pharma should be looking at the bigger picture, and advocate a global standards-based approach to anti-counterfeiting.  
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The EU this year revised its guidelines on type size in pharmaceutical labelling. Kurt Kjellerup of CCL Label Copenhagen reviews the updates, and describes ways in which pharmaceutical companies can achieve compliance.  
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Anti-Counterfeiting
In response to the prevalent issue of drug counterfeiting, pharma has developed countless technological solutions. Narendra Srivatsa at Cortegra investigates the options currently available, looking at the benefits and advantages of different anti-counterfeiting strategies.  
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One specific and perhaps less explored technological solution is energy dispersive x-ray diffraction, which allows molecular screening of a product inside its original container. Alan Clock at XStream Systems introduces the technology and outlines its considerable benefits.  
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FORMULATION, Ingredients & Excipients
Good manufacturing practice exists as a crucial benchmark for most areas of pharmaceutical production, but not for excipients. Phil Taylor, consultant writer for the International Pharmaceutical Excipients Council, proposes third-party certification as an alternative means of quality assurance.  
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Edited by
Randice Altschul
Chief Executive Officer at Pop Test and Palisades Therapeutics

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