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Pharmaceutical Manufacturing and Packing Sourcer

pmps
Summer 2010
   
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Manufacturing
JD Hansford of the Institute of Decontamination Sciences illustrates the path that sterile services have taken in the last half-century, from humble beginnings in war-time hospitals, through the development of single-use equipment, to the well-regulated and essential processes in operation today.  
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Michael Tschöpe at Excella GmbH provides insight into some of the challenges involved in manufacturing active pharmaceutical ingredients, including the capabilities and qualities to look for when evaluating a contract manufacturer.  
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For a contract manufacturer to emerge as a true business partner for their customers, operational excellence must be a top priority. Olaf Schrake at Hameln Pharmaceuticals GmbH sets out the criteria upon which the foundations of a sturdy partnership should be built.  
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Extractables pose a considerable threat to the integrity of parenteral drug products, and should be taken account of suitably in the manufacturing process. Diane Paskiet of West Pharmaceutical Services gives some examples of how this can effectively be achieved.  
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Cool Chain, Cargo & Logistics
Evaporative cooling has been used by man for thousands of years in various guises, but is only now being applied in cool chain transport. Richard Harrop at SCA Cool Logistics shows how the technology is coming into its own.  
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Joe Fudge at ABB Instrumentation answers questions about cold chain mapping and the importance of selecting the right supplier for the service, as well as addressing key issues relating to current regulations and best practice.  
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With their large populations, vast geographical areas and varying climates, Brazil, Russia, India and China represent a particular challenge in pharmaceutical logistics and clinical trials planning, explains Alex Klim at DHL Supply Chain.  
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Drug Delivery 
Thakur R Raj Singh, Rita Majithiya, Rahamatullah Shaikh, Yusuf Kemal Demir and Ryan Donnelly of Queen’s University Belfast provide an insight into the world of microneedle-based transdermal delivery systems.  
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When it comes to drug delivery on the hospital floor, plenty of issues still need to be addressed in order to improve the safety of staff and patients. Danielle Labreche of Laboratoire AGUETTANT provides examples of syringe solutions technology that can minimise the risk of injury and infection.  
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Michael J Rathbone of Griffith University, Australia and Padma V Devarajan of the Institute of Chemical Technology,Mumbai discuss tools that can potentially bridge the gap between human and veterinary controlled release, and show how each field can learn from the other.  
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Packaging, Packing & Anti-Counterfeiting
Current labelling legislation for pharmaceutical packaging calls for a wide range of information to be displayed.Mark Beauchamp of Citizen Systems Europe provides an overview of technologies that manufacturers can employ to meet these requirements.  
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Valérie Marchand of GS1 France and Frédéric Lemaire at Avery Dennison focus on DataMatrix barcoding – an affordable way to improve the security and traceability of drug products, as well as conforming to regulatory standards.  
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In addition to its impact on manufacturing itself, contamination continues to be an issue after a product has been packed and sealed, in the form of extractables and leachables, as Julian Rae at Reading Scientific Services Ltd explains.  
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Roy Cannon at Teknek gives the lowdown on contact cleaning technology, its importance in combating viable contamination, and the principles of good manufacturing practice that must be adhered to in the packaging process.  
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Formulations, Ingredients and Excipients
Custom synthesis of molecules requires a range of strong working partnerships to achieve a top-quality product.Tony Flinn at Onyx Scientific Ltd highlights the most important connections, and points to some key decisions that need to be made before a supplier can be chosen.  
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The key developments in the current landscape of synthesis outsourcing are illustrated by Guillermo Morales, Bryan K Roland and Emile Bellott at AsisChem Inc, who expect positive progress in the next few years for the CROs operating in this field.  
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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

POP TEST ADDRESSES THE PROBLEM OF UNRELIABLE DATA FROM CONTINUOUS GLUCOSE MONITORS

A major insight relating to the unreliability of data from continuous glucose monitors was published in the Nature journal, “Scientific Reports”, by Neil Theise, MD., the Lead Scientist of Pop Test, LLC and colleagues. The discovery of the “Interstitium”, a newfound human organ, by Dr. Theise and his collaborators, can be viewed by using the link https://www.nature.com/articles/s41598-018-23062-6 Continual glucose monitoring via an indwelling cutaneous needle measuring glucose in interstitial fluid (now identified to be in the “interstitium”) has been a game changer in the treatment of type 1 diabetes mellitus because of its accuracy. However, the needles used to collect this glucose containing fluid often fail in as little as a week. Despite the reliance on fluid from this space, the microanatomy of the interstitium has never been defined. The sensors currently in use were developed with the presumption of interstitial fluid being located somewhere in the sub-epidermal layers of the skin, but the actual anatomy relating to needle placement was always unclear.
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White Papers

Case Study: Emerade® Auto-Injector

SHL Group

The Emerade® Auto Injector is an intuitive disposable 2-step auto injector designed to deliver adrenaline via intramuscular injection during emergency use. The exterior of the device has a simple and sleek industrial design with the aim to minimize confusion for users. To achieve the penetration force required for an intramuscular injection while still ensuring the dosage is delivered correctly and needle protection mechanisms are in place, the Emerade Auto Injector is equipped with an advanced 3 spring technology. The device is also available in 3 doses (150mcg, 300mcg, 500mcg), with each recommended for patients of different bodyweights to maximize efficacy.
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Industry Events

Cell Line Development and Engineering

23-25 April 2018, RAI, Amsterdam

Cell Line Development & Engineering 2018 event will be held 23-25 April 2018 in the RAI Amsterdam – joining the largest Bioprocessing event in Europe – BPI Europe.
More info >>

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