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| home > white papers > Analysis of Biopharmaceuticals to Conform to ICHQ6B - RSSL |
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 WHITE PAPERS |
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RSSL
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+44 (0)118 918 4024
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http://www.rssl.com
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University of Reading, Whiteknights Rd, Reading, West Berkshire RG6 6LA
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Analysis of Biopharmaceuticals to Conform to ICHQ6B
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Worldwide, the pharmaceuticals market is anticipated to grow from more
than USD 782 billion in 2011 to approach a value of just over USD 971
billion by the end of 2016, registering a CAGR of over 24%. In 2010 the
average medicines expenditure per person within the UK was £271, and
this is expected to increase with the ageing population. A significant
and increasing proportion of these sales are protein-based
biotherapeutics or biomolecules. Currently, these account for 19% of the
total market, and are growing at twice the rate of traditional small
molecule pharmaceuticals. It is predicted that close to 50% of the top
100 pharmaceutical products will be biomolecules by 2016. By far the
largest segment of the biopharmaceutical market is the monoclonal
antibody (MAb) with an estimated share of 25.6%, which corresponds to
USD 51.1 billion.
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News and Press Releases |
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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 >> |
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White Papers |
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Transforming Temperature Data Management Practices to Reduce Labor Costs and Improve Visibility and Control
Berlinger & Co AG
There are a number of temperature monitoring database options available to the biopharma supply chain professional and choosing the right one can significantly improve workflow which will reduce administrative time. This article will provide insight into practices for improving common processes through enhanced database functionality in the areas of managing data loggers by expiry date, storing and retrieving calibration certificates and acknowledging/documenting common temperature excursion events. Additionally, it describes the unique features and benefits of the Berlinger Smartview® data management system. Smartview® is a “Software as a Service” (SaaS) platform designed to efficiently and accurately manage both workflow and data in a regulatory compliant manner (21 CRF Part 11 & Annex 11). This comprehensive temperature data management system ensures reliability, accuracy, security, accessibility, and visibility to supply chain professionals, enhancing Good Distribution Practices (GDP) of temperature sensitive shipments.
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Industry Events |
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Clinical Trial Supply Europe 2019
13-14 March 2019, Milan, Italy
Following
on from our largest and most engaging meeting to date, Clinical Trial Supply
Europe will be returning to Milan for its 20th year in 2019!
The
19th annual edition welcomed pharmaceutical companies across Europe who got
together to share knowledge and issues regarding clinical trial supplies, both
with regards to operational and technological challenges. Over the two days,
delegates discussed issues which affected their business in our dedicated
operational and technological streams.
More info >> |
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