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Pharmaceutical Manufacturing and Packing Sourcer

pmps
Summer 2009

Pharmaceutical Manufacturing and Packing Sourcer (PMPS) is a specialist journal designed to provide worldwide coverage of a range of topics relating to the pharmaceutical manufacturing and packaging sector.

Published quarterly, the journal functions as a platform of communication and information-sharing for executive and strategic decision-makers within the industry, identifying new trends and marketing opportunities as well as highlighting the latest innovations in this dynamic environment. PMPS is specifically designed to interest those in the pharmaceutical, biotech, nutritional and medical device industries who are actively seeking to source services for improved efficiency in what is an increasingly competitive market.

   
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Manufacturing
The management of processes which span the supply chain presents a considerable challenge to pharmaceutical executives. Stefano Bergantino at Accenture proposes enterprise resource planning as a means by which meeting these challenges can be facilitated.  
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The manufacture of drugs typically follows a stepwise process. While this makes the preparation of new drugs easier, it may preclude innovation and improvement. Adrian Howson at Sagentia Limited introduces continuous processing as the forward for manufacturing.  
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Reactors used in pharmaceutical manufacturing must be durable in order to withstand the chemical recations which take place inside them, and to meet FDA and GMP requirements. Kerry Clunie at Pfaudler Balfour investigates how glass-lined reactors can offer this benefit, while also being conveniently lightweight.

 
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Many drug manufacturing cycles use lyophilisation at some stage, but may not be doing so efficiently. Jorge Sassone at Improvement-Proquimo do Brazil, Enric Jo and Laura Noguera at Reig Jofre Group, and JR Mullick at Klenzaids discuss how the full benefit can be derived from the lyophilisation process.  
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Pharma is not known for its ability to learn from other industries, and this is holding the sector back, claims Paul Beaumont at WCI Consulting, who goes on to outline the benefits that could be gained from a more open approach in this area.  
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Cool Chain, Cargo & Logistics
The globalisation of the pharmaceutical supply chain has seen an increasing demand on air cargo as a means of cold chain shipping. Mark Mohr at Continental Airlines Cargo suggests that this change in demand has helped to accelerate the evolution of the air cargo industry as a whole.  
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Another industry sector which has had to adapt to serve the demands of the pharmaceutical industry is road transportation, but now it is time to look beyond the provision of temperature-controlled vehicles, argues Jason Breakwell at Rutges Cargo.  
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One of the options open to companies seeking to distribute products via road is the pallet network - the ideal solution in the current climate, asserts Craig Hibbert of Palletways' UK Member Network.  
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Security is a prerequisite in the distribution of drugs; Mark Beauchamp at Citizen Systems looks at how labelling technology can safeguard pharmaceuticals on their journey through the supply chain.  
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Drug Delivery 
Since the introduction of the first mechanical spray pump for nasal drug delivery in the early 1970s, such devices have undergone constant improvement. Hervé Pacaud at Valois Pharma identifies patient-independent features as the next step towards the paradigm of the fully compliant device.  
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Mark Copley at Copley Scientific provides an overview of the benefits of pulmonary drug delivery, and of advances in the development of inhaled drug delivery systems.  
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Formulations, Ingredients and Excipients
Adrian Possumato at Multisorb Technologies explores how pseudo-empirical modelling can be used to investigate the relationship between drug formulations and their packaging environment.  
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Maxime Laugier at MP5 outlines the challenges facing formulation scientists developing injectable biopharmaceuticals, and guides us through the ways in which they can be overcome.

 
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PACKING, PACKAGING & ANTI-COUNTERFEITING

The EU BRIDGE project seeks to develop a complete item-level traceability system for the pharmaceutical supply chain. John Jenkins at JJ Associates introduces the project, and explains how it will benefit the industry as a whole.

 
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The sheer size of the pharmaceutical market and the advent of the internet mean that the absolute prevention of counterfeit drug sales is now impossible, but, says Philip Payne at RSSL Pharma, each party involved along the line should do their best to crack down on the problem.  
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Advanced technology and a well-developed security stratey are key weapons in the war against counterfeits. Loius M Parks at SecureRF Corporation describes how the two can work together to provide the highest level of protection.  
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Blisterpacks are an example of a packaging type which demands specialised security features. Cathy Brown at Napp Pharmaceuticals Limited identifies these features, and explains what else can be done to ensure the safety of blisterpacks.  
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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

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Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation. The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems. As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
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Industry Events

ChinaBio Partnering Forum 2018

25-26 April 2018, Kempinski Hotel Suzhou, Jiangsu, China

Access a world of opportunities through life science partnering in China. ChinaBio® Partnering Forum is the premier life science partnering event in China. The conference will be held April 25–26 in Suzhou, attracting biotech and pharma leaders from around the world along with hundreds of China-based developers of novel technologies for two days of productive partnering.
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