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Pharmaceutical Manufacturing and Packing Sourcer

pmps
Winter 2011

   
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Industry Insight 
To celebrate PMPS’ 50th issue,Accenture Partner and PMPS Editor Bruce Horton provides an analysis of the industry’s progress since the first edition was published in 1998, and considers where we stand now and the developments that lie ahead.  
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PMPS has seen a wealth of progress in the pharmaceutical world, as well as the full spectrum of economic change and huge strides in R&D.We ask leaders in key sectors to give their views on the future of the industry.
 
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Manufacturing
Mark Jennings at Dawson Shanahan Ltd introduces coldforming – a technique that can unlock faster and cheaper drug delivery device production – and offers a straightforward means of regulatory compliance.
 
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Andrew Barrow at Cherwell Laboratories points out the importance of an aseptic filling environment for biological products, and shows how the process should be carried out in line with GMP requirements.
 
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Mark Thompson and Sharon Smith at the Honeyman Group Ltd analyse the steam sterilisation process in detail and discuss how a good qualification study is of great importance when demonstrating its effectiveness.
 
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Cool Chain, Cargo & Logistics
Suzanne Parish at DHL makes a case for six key elements of communication in the clinical trials supply chain.
 
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Thermal requirements and material restrictions are essential elements of temperature-controlled packaging design, explains Alex Roskoss at Intelsius.
 
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Biological medicines and products present a unique set of challenges for the transporter. Federico Lupp at LifeConEx reviews the steps that must be taken to ensure a smooth journey.
 
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Kenneth T Lukes at Inmark Inc assesses the recent thermal test standard from ISTA and considers whether it has the potential to be a universally adopted regulation.  
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Drug Delivery 
Modern manufacturers, as well as the patients they serve, need much more efficient and effective delivery devices than today’s market is able to provide. Phil Lever at Cambridge Consultants picks out ways in which devices can be brought up to scratch.
 
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When bringing a drug delivery device into the US market, there are several considerations to tackle in order to enjoy a fruitful encounter with the patent process, as Clifford M Davidson at Davidson, Davidson & Kappel LLC shows.
 
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The astute drug manufacturer will assess a range of nasal, pulmonary and ophthalmic drug delivery devices to find the right vehicle for their product. Gerallt Williams at Aptar Pharma gives an overview of the various technologies and the features they offer.
 
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Bob Sharp and Paul Whyte at Future Injection Technologies Ltd analyse the future requirements of the NHS for injectables and identify patient behaviour as the key factor in the selection of delivery platforms.
 
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Labelling 
The pharmaceutical packaging and labelling industry is breaking into new territories more than ever before and with this progress comes the challenge of translation management, as Neil Gleghorn at Kallik explains.
 
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Packaging, Packing & Anti-Counterfeiting
Adrian Burden at Bilcare Technologies highlights potential technology combinations in today’s devicedriven marketplace, and argues that anti-counterfeiting initiatives should take advantage of the options available to ensure product security.
 
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Joseph Ringwood at Systech International takes a look at aggregation in product tracking, showing that it must be used in conjunction with serialisation in order to achieve a successful track and trace programme.
 
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Dean Chespy at Siemens Industry Automation explains how the efficiency gains offered by RFID, serialisation and ePedigree initiatives can benefit the whole industry, eliminating human failure and slashing costs as a result.  
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Formulations, Ingredients and Excipients
The unique, demanding requirements of protein-based biological products can throw up a range of problems during their formulation. Carsten Olbrich at Bayer Schering Pharma AG looks at how these can be overcome.  
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The End of the line
No matter how cool it keeps a product, a thermal packaging solution is no use if it can’t take a knock, as Richard Harrop discovers.  
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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

Genome & Company Chooses Luina Bio to Supply Innovative Drug Productfor Clinical Trials Programme

Luina Bio, a leading biopharmaceutical manufacturing company in Australia, today announced it will develop and produce an innovative bacterial drug product for Genome & Company to support its clinical trials programme. The relationship signals Luina Bio’s first foray into Asia and further establishes its global leadership in the current Good Manufacturing Practise for microbiome projects.
More info >>

White Papers

Bringing more control to temperature-sensitive logistics

UPS Supply Chain Solutions

By 2016, world sales of cold-chain drugs and biologics such as vaccines and blood plasma products will near $240 billion1. The increase has led to a surge in discussion about how to protect these products throughout the transportation logistics cycle. Industry experts are recommending that the term “cold chain” be eliminated from rules, guidance and best-practice documents. “Cold chain” now includes a broader spectrum of temperature ranges, such as controlled room temperature (CRT). This white paper focuses on the initial steps required to establish a temperature-sensitive supply chain.
More info >>

Industry Events

10th Annual Summit for Clinical Ops Executives

18-21 February 2019, Hyatt Regency Orlando, Florida

Celebrating its 10th successful year, SCOPE Summit 2019 takes place February 18-21 in Orlando, FL. Over the course of four stimulating days of in-depth discussions in 19 different conferences, 3 plenary keynote sessions, and the ever-popular interactive breakout discussions, the programming focuses on advances and innovative solutions in all aspects of clinical trial planning, management and operations, including...
More info >>

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