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Pharmaceutical Manufacturing and Packing Sourcer

pmps
Spring 2010

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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Manufacturing
With non-GMP regulations leading to an overlap between the roles of the Qualified Persons in pharmacovigilance and manufacturing,Marty Boom of WCI explains how any tensions should be avoided, as both ultimately have the same goals.  
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Sean L Kitson at Almac shows how synthetic organic chemistry, key technologies (such as radiolabelling) and cGMP must be combined in the drug manufacturing process to achieve the highest standards possible.  
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Mark Botting at Isotron highlights the importance of a variety of techniques which allow the contract steriliser and manufacturer to achieve the required regulatory targets.  
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Process analytical technology provides manufacturers with an essential tool in dealing with the crucial market drivers that shape a pharma company’s strategy, explains Dean Chespy at Siemens Industry Automation.  
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Rodolfo Valdés and his team from the Center for Genetic Engineering and Biotechnology, Havana, Cuba focus on immunoaffinity chromatography in vaccine manufacturing, and provide a detailed example of its application.  
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Chuck Reed at Weiler Engineering analyses how modern aseptic blow-fill-seal technology can improve the speed and quality of liquid manufacture, while also offering stronger protection against contamination.  
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Polymeric flooring is a far more effective solution to cleanroom particulate contamination than other technologies such as peel-off mats, writes Gerry Prout at Dycem.  
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Cool Chain, Cargo & Logistics

Real-time tracking technologies and their perceived effectiveness in business are examined by David Bang of LifeConEx, who points out the apparent lack of actual examples.

 
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New and thorough air cargo screening regulations are coming into force in the near future, and will put pharma transport contractors to the test – especially those that are unprepared, explains independent writer Robert Moorman.

 
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Drug Delivery 
Rania Salama of the University of Sydney, Australia shows how several characteristics of the human lung make it a highly effective location for the administration of treatments for pulmonary disease, although there are plenty of challenges facing the controlled release manufacturer.  
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Transdermal deliveries offer an empirically proven solution to controlled release for a wide range of conditions, according to Robert Falcone of the New Jersey Institute of Technology and Bozena Michniak-Kohn of the State University of New Jersey, who go on to highlight current approaches and technologies.  
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Maxime Laugier at MP5/CREAPHARM discusses strategies to avoid crosscontamination in the manufacture of drug delivery systems, and assesses the differences between single and multi-use equipment.  
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Packaging, Packing & Anti-Counterfeiting
Counterfeit drugs present a real and tangible threat to manufacturers and distributors alike, says Vince Postill of PRISYM ID, who outlines the measures available to halt their spread.  
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Frederic Menardo of Systech International and Graham Smith of Aegate argue that serialisation technology must be more widely taken up by the pharma industry, particularly in the face of impending anti-counterfeiting legislation.  
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As well as providing effective weapons against product piracy, serialisation and track and trace technologies can also add value to genuine products, points out Steve Wood at COVECTRA.  
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Non-adherence is a major problem in the healthcare industry;Ted Lithgow at MWV explains that innovation is required to reduce the scale of the issue, with adherenceenhancing packaging presenting an effective and cost-reducing solution.  
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Formulations, Ingredients and Excipients
Jorge Sassone of Improvement-Proquimo provides a detailed analysis of formulation in the lyophilisation process, outlining the essentials of each stage and their importance.  
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Lyn Hughes of Dow Water and Process Solutions argues that taste-masking improves adherence and can give a manufacturer a competitive advantage.  
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Edited by
Randice Altschul
Chief Executive Officer at Pop Test and Palisades Therapeutics

Published quarterly in
February, May,
August and November

News and Press Releases

Strategic Alliance to support efficient, ethical practices in biopharma industry

Hayward, CA and Stockholm, Sweden (07-12-2017) – Two leading drug development and regulatory consultancies announced today that they have formed a new strategic collaboration to help life science companies navigate an increasingly complex global environment. Ethiprax Associates LLC, a leading Compliance and Ethics solutions consultancy based in the US, and NDA Group, a world-leading integrated regulatory/drug development consultancy, are now collaborating to provide the life science industry with truly integrated, trans-Atlantic Compliance-and Risk Management strategies.
More info >>

White Papers

Unmet Medical Needs? Impacted by unmet Life Sciences Staffing Needs?

Clinical Professionals

Whilst the majority of Clinical Professionals clients are working to discover and develop innovative, cost effective medicines that address unmet medical needs they are not impacting the unmet needs of training and developing new recruits into the pharma industry. The impact is highlighted within entry level Clinical Trial Administrators and Clinical Research Associates (CTA/CRA). In the past the Pharmaceutical industry had highly developed training programs for these sought after candidates. As the use of outsourcing models and CRO’s has increased and fewer Pharma businesses embark on their own R&D a substantial gap is developing in newly trained Life Science graduates entering the market to commence a career within R&D. As further financial cuts are made within R&D spend this already dire situation continues to escalate.
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Industry Events

14th World Advanced Therapies & Regenerative Medicine Congress 2018

16-18 May 2018, Business Design Centre, London, United Kingdom

In May 2018 the World Advanced Therapies & Regenerative Medicine Congress, will bring together 800+ attendees and explore the rapidly developing world of ATMPs (Advanced Therapy Medicinal Products).
More info >>

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