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Issue #5 2016 – Digital edition
20 October 2016 | By European Pharmaceutical Review
In this issue: Biosimilars, Informatics, Ingredients, PAT, HPLC, Microbiology, Product Showcase, Regulation, and much more...
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Issue 5 2016
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Product Showcase 2016
This product showcase features articles from Charles River, Eppendorf Inc. and Eurofins Lancaster Laboratories...
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Ingredients In-Depth Focus 2016
In this Ingredients In-Depth Focus: Excipient quality and supplier interchangeability; Interpreting ICH’s evolving residual solvents guideline; Q&A with Meggle...
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HPLC In-Depth Focus 2016
In this HPLC In-Depth Focus: Resolving natural compound complexity with multidimensional chromatography; The advantages of temperature elevations in HPLC...
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Biosimilars: litigation outlook
In the Foreword article contributed by Consultant David P. Elder in Issue 3, 2016 of European Pharmaceutical Review, entitled ‘Biosimilars: future prospects’, Dr Elder concluded that it is likely that biosimilars will become increasingly established in both Europe and the United States and that in addition to proteins and peptides,…
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Security considerations for external research
Intellectual Property (IP) is the lifeblood of the pharmaceutical industry. Without it, there would not be much of a business. Growing research and development globalisation, externalisation, the expansion of electronic data management systems and the lack of consistent global IP enforcement is increasing the capacity of external and internal parties…
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At-line swabbing analysis as a process analytical tool
20 October 2016 | By Adeyinka Aina and Chris Edlin, Pharmaceutical Manufacturing Technology Centre
Swabbing is a technique commonly used during pharmaceutical cleaning protocols to ensure that the cleaning process meets both safety and regulatory requirements; this allows for the cleaning process to be subsequently verified and validated1-7.
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Managing contamination risks in glove holes in barrier separation technology
The manufacture of sterile medicinal and therapeutic products increasingly calls for aseptic processing using barrier separation technology comprising isolators and restricted access barrier systems (RABS) that have glove-sleeve systems.
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Understanding today’s drug pricing environment
In a healthcare world that experiences a plethora of high-cost new therapies coming to market in parallel with price increases for existing speciality drugs, pharmaceutical companies are having to move away from traditional pricing models that are largely based on demand and what the market will bear. At the same…
