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Pharmaceutical Manufacturing and Packing Sourcer

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Autumn 2005
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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Industry Insight 
In her Editor’s Letter, Patricia Lobo introduces the articles in this issue  
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Manufacturing
Karen Rossington,Marketing Manager at Shield Medicare Ltd, puts the cleaning and disinfection of an isolated system using liquid sanitation methods under the microscope, in Correct Cleaning of Pharmaceutical Isolators  
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The growth of Six Sigma continues apace.Mark Jamieson, Director of Six Sigma, and Keith Wellington, Project Manager at Celerant Consulting, outline the reasons for its success, in Six Sigma in the Pharmaceutical Industry: Tackling the Cost of Quality  
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In Hydrogen Peroxide Vapour: The New ‘Gold Standard’ for Bio-decontamination, Jonathan Otter, Lead Microbiologist, and Dr Rachel Jarman-Smith, RBDS Pharmaceutical Sales Manager at Bioquell UK Ltd, explain how HPV is quickly establishing itself as the most popular agent for bio-decontamination  
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Effective sterilisation remains paramount during drug manufacture – Phil Smith, Pharmaceutical Marketing Manager at Oxoid Ltd, suggests one way of achieving this, in Media Fill Contamination – Are You Looking in the Right Place?  
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Packaging, Packing & Anti-Counterfeiting
Increasing reliance on the packaging industry to combat product tampering means that creative solutions are constantly being sought. Bruce Drew,Managing Director of Aquasol Ltd, suggests an innovative method, in Packaging and Delivery-System Advancements in the Pharmaceutical Industry  
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Developments in labelling legislation have meant that new systems must overcome certain hurdles in order to incorporate these changes, says Peter Lees, Sales Director at PALS Labelling, in Latest Innovations in Labelling Technology Help Compliance with New Legislation  
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In Regulatory Requirements of Pharmaceutical Packaging: Utilising Automated Workflow Systems, Andy Carrier,Managing Director of ARK Pharma Graphics, addresses the minefields that artwork for pharmaceutical packaging must navigate around  
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PMPS talks to Bruno Oberle, Head of Marketing and Business Development at Sigpack Systems  
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Formulations, Ingredients and Excipients
The influx of new drugs on the market is revolutionising production and regulation processes, contends Dr Maria Luisa Nolli, CEO at Areta International srl, in A Quality-Based Strategy for the Process Development and Manufacturing of Batches of Antibodies for Therapy  
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Professor Rudolf Lucas, Chair of Medical Biotechnology at the University of Applied Sciences, investigates a method which has potential to effectively treat pulmonary oedema and acute lung injury, in Preclinical Evaluation of a TNF-derived Peptide in Models of Experimental Pulmonary Oedema  
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Dosage Forms
Dr Ewart T Cole,Director of Product Development at the Capsugel Division of Pfizer Inc, reviews the new ways in which hard gelatin capsules are being formulated in order to keep up with market demand, in Liquid Filled and Sealed Hard Gelatin Capsules  
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The importance of protective coatings can be reflected in the fact that performance failings require an explanation.Tony Kinsella,Managing Director and Commercial Director at CSMA Ltd, demonstrates a way of providing one, in The Future of Surface Analysis  
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Nasal and Pulmonary Drug Delivery
Dr Ola Nerbrink, Principal Scientist at Novo Nordisk, provides us with a history of the treatment of respiratory disease, in The Early Development of Inhalation Therapy and Device with Specific Emphasis on Liquid Systems  
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All levels of asthma can be controlled with the correct administration of a care strategy, asserts Mike Sullivan,Vice President, R&D and International Projects, at Rosti Technical Plastics, in The Innovative Bio Feedback Module Signals New Era in Asthma-Patient Care  
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PMPS in conversation with Helder Mota-Filipe,Vice President, Executive Board of the Portuguese Medicines Agency  
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Drug Delivery
In the growing market for pens and auto-injectors, prefilled injectors are leading the way for self injections and are consequently becoming more straightforward to use, argues Ian Thompson, Business Development Manager at Ypsomed, in New-Generation Auto-Injectors: Completing the Scale of Convenience for Self-Injection  
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In Contemporary Perspectives on Topical Drug Delivery, Dr Charles M Heard, Lecturer,Welsh School of Pharmacy at Cardiff University, presents new developments for that familiar route for drug delivery; the skin  
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Pharmapack 2010 supplement
The numerous challenges which confront the manufacturing sector makes outsourcing an increasingly relevant option, states Ingela Hermann, Head of Marketing and Sales at Cenexi, in Subcontracting – The Antidote to Production Pressures  
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In Handling Clinical Trial Materials in Russia, Dr Sergei Varshavsky, Chairman and CEO, Olga Markovskaya, Pharm D, Director of Drug and Clinical Supply Depot, and Nikolay Truzhenikov, Global Logistics Director at Evidence Clinical and Pharmaceutical Research, make the case for using the country as a future location for clinical trials

 
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IT and Logistics
In Qualification Versus Validation and Good Cold Chain Management Practices, Rafik H. Bishara, PhD, Technical Advisor to Sensitech, Inc, clarifies terms which have led to some confusion within the pharmaceutical industry  
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Steve Parton, Rental Sales Manger at Simons Reeve Ltd, maintains that the enhancement of the logistics process is key to reducing cost; he shows us one way to do this in New Generation Plastic IBCs: The Benefits for Bulk Handling  
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IT plays an essential role in the move towards a more secure supply chain, according to Marc Bray, Marketing Director at Logys, in Securing the Drug Supply Chain: IT Solutions to Ensure Improved Track and Trace  
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Validation & Compliance
Pharmaceutical marketing practices are undergoing a rigorous period of enforcement activity – Linda R Horton, Partner at Hogan & Hartson LLP, reports on the emerging trends, in Pharmaceutical Marketing Practices: European Authorities Tighten Controls  
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In High-Throughput Testing – Penetrating Pharmaceutical and Manufacturing Process Development, Adrian Howson,Managing Consultant, Product & Process Engineering at PA Consulting Group, presents the two factors which are acting as drivers for change in pharmaceutical development groups  
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Previews
Have you got your ticket for this year’s CPhI? Here’s a brief taster of what you can look forward to  
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ViB events showcase the Third Annual Biological Manufacturing, which is taking place in London on 22nd-23rd November  
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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

Bigneat is awarded the Queen’s Award by Lord-Lieutenant of Hampshire

Bigneat Ltd, winner of a Queen’s Award for Enterprise earlier this year, received their Award from Nigel Atkinson Esq, HM Lord-Lieutenant of Hampshire on 16th October at the Bigneat factory in Waterlooville.
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White Papers

Recommendations for Implementing Assessment Criteria Guidelines in Lymphoma and Chronic Lymphocytic Leukemia Clinical Trials

Perceptive Informatics

Standardized assessment criteria are becoming increasingly important in obtaining valid outcomes in oncology clinical trials. While standardized criteria encourage a more uniform approach to assessing clinical trial data, they are often subject to the interpretation of the user. These differences in interpretation, while seemingly minor, can have a major impact on assessments. The most commonly used standardized criteria for lymphoma have been no exception. Differences such as minimum new lesion size, lymph node normalization size requirements, inclusion of extranodal lesions and assessment of organomegaly can have a profound effect on overall response. Additionally, heightened scrutiny of the assessment criteria used in a given protocol can lead to questions about a drug’s efficacy if not applied correctly according to regulators’ interpretation.
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Industry Events

Drug Discovery 2018

21-22 March 2018, Copthorne Tara Hotel, Scarsdale Place, Kensington, London

SMi Group is proud to announce the return of Drug Discovery in 2018. The successful conference will return for its 2nd year on the 21st and 22nd March.
More info >>

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