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PUBLICATIONS

Pharmaceutical Manufacturing and Packing Sourcer

pmps
Autumn 2010
   
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Manufacturing
Yaniv Vardi at Sparta Systems Europe Ltd argues that enterprise-wide quality management systems need to be seriously considered by manufacturers for their ability to streamline processes, centralise reporting and reduce unnecessary overheads.  
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Cool Chain, Cargo & Logistics
Edward A Church of the International Safe Transit Association presents the new ISTA Standard 20 while looking at the effect it will have on the shipping of temperature-controlled products, including opinions from industry insiders.  
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Rather than constantly purchasing and disposing of temperature-controlled packaging for thermal shipping, companies can look to recycling previously used materials that are still just as effective for the task, argues Brian Kohr at AcuTemp Thermal Systems.  
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Abbes Kacimi at Sofrigam weighs up the advantages and disadvantages of temperature-controlled packaging and refrigerated trucks, and offers advice on choosing between the two solutions when deciding upon a transport programme.  
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Training and communication are the two fundamental pillars of any cool chain partnership. Ameet Sareen at Air Canada Cargo looks at their integration in each link in the chain and gives an example of a case where both were indispensable.  
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Logistical considerations as a whole must be near the top of any pharma company’s to-do list. Johan Beukema at Buck Consultants International looks at outsourcing logistics to service providers and considers whether this is a viable path to take in the current climate.  
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Packaging, Packing & Anti-Counterfeiting
Roland Meylan at AlpVision shows how serialisation and authentication technologies must work together in order to safeguard products at all stages in the supply chain and to guarantee the safety of the patients they have been designed to protect.  
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Lene Blanke at Promens Medical Packaging explains that, to ensure commercial safety and viability, primary packaging should be processed thoroughly and in partnership with all parties involved, including designers, engineers and suppliers.  
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Gaëlle Janssens at PRO EUROPE and consultant Attilio Caligiani give an account of sustainable solutions and measures that can be employed by the packaging industry to maintain EU standards and to ensure products are environmentally friendly.  
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The very last stage of the packaging process creates what the consumer will finally see. Sue Benson at The Market Creative highlights some examples of how design features can improve brand awareness and contribute to compliance.  
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Formulations, Ingredients and Excipients
Harald Stahl at GEA Pharma Systems picks out five types of granulation process currently in use, highlighting the advantages and disadvantages of each and explaining how to select the process that will best meet your company’s production requirements.  
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Drug Delivery

With frequent and continuous innovations being produced in the drug delivery industry, the need for results can often obstruct the creativity that leads to true value. David Harris and Ross Jones at Sagentia consider the current situation and how it can be improved.

 
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Providing patients with training devices for certain delivery forms allows them to get used to the real thing, which in turn improves compliance and confidence, argues Matt Coe at One World Design & Manufacturing Group.  
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Frank Richter at RAUMEDIC AG explains how devices that resemble the function of familiar apparatus gives comfort to patients – especially children – which encourages compliant behaviour and can also ensure correct dosage.  
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MANUFACTURING
Simon Clough at Aesica Pharmaceuticals gives an assessment of how the regulatory, logistical and management challenges of manufacturing Schedule 2 controlled drugs can be overcome, while providing details of the legislation involved and the current market situation in the UK.  
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As their name suggests, single-use medical devices are traditionally rejected after application. However, Xiang Zhang at CERAM shows that effective sterilisation processes can often be employed by manufacturers to enable reprocessing and ultimately re-use.  
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the end of the line

Richard Harrop takes a sideways look at temperature-controlled packaging.

 
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News and Press Releases

CPI to showcase results from BioStreamline project developing novel biotherapeutics

CPI, a UK-based technology innovation centre and a founding member of the High Value Manufacturing Catapult, announced today that it will host an event in Darlington, UK on 26 June 2019 to disseminate the results of the £11.2M BioStreamline project to optimise the development of novel therapeutics. During the event, the project partners — Lonza Biologics, UCB Celltech, Sphere Fluidics, Horizon Discovery Group plc (Horizon), Alcyomics Ltd and CPI — will showcase the results and discuss the potential impact on overcoming some of the most significant shortcomings of the biologics supply chain.
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White Papers

The BioPharmaSpec Approach”: Mass Spectrometry Based Host Cell Protein Identification and Quantitation

BioPharmaSpec

1. Introduction As part of the development of any biopharmaceutical product, the impurities present must be examined, minimized and where possible characterized (1). These impurities fall into two broad categories: product-related impurities (derived specifically from the drug product itself) and process-related impurities (derived from material associated with the production, processing or purification of the sample). Host cell proteins (HCPs) are process-related impurities that require specific analysis due to the multitude of naturally occurring proteins expressed in the production cell line.
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Industry Events

Clinical Trial Supply Europe

11-12 March 2020, Madrid, Spain

The 21st annual edition promises to grow on the success of 2019’s excellent conference which saw delegates from Europe’s largest pharmaceutical companies and biotech innovators come together to discuss, debate and unpack the latest trends in clinical supply chain innovation. 2020 will offer delegates the opportunity to address the growing need for agility within the supply chain in response to increasingly complex trial demands. With a stream dedicated to supply operations and another to innovative uses of technology in the supply chain, delegates will get the chance to gain practical take-aways that they can apply to their own studies.
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