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Pharmaceutical Manufacturing and Packing Sourcer |
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| 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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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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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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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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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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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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| 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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| 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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News and Press Releases |
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Sartorius Stedim Biotech Launches New Services for Mammalian Cell Bank Manufacturing
GOETTINGEN, Germany and GLASGOW, UK, August 08, 2019 / B3C newswire / -- Sartorius Stedim Biotech (SSB), a leading partner of the biopharmaceutical industry, today announced the launch of new services for mammalian cell bank manufacture under GMP conditions. These services are offered by its subsidiary, Sartorius Stedim BioOutsource, an experienced contract testing organization (CTO) based in Glasgow, UK, and in Cambridge, Massachusetts, USA.
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White Papers |
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7 Common Myths about QP Training Debunked: A Guide for Senior Managers
RSSL
The role of the Qualified Person (QP) in the pharmaceutical industry is mandated by law (Directive 2001/83/EC, Directive 2001/20/EC, UK SI 2012/1916, UK SI 2004/103). Every holder of a relevant Manufacturers Authorisation (human and veterinary) must have at least one QP; without one, no batch of medicinal product can be certified for release for sale.
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Industry Events |
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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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