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15 April 2017 | By Ioannis A Papayannopoulos ( Celldex Therapeutics)
Biological products, usually referred to as biologics, constitute a significant segment of pharmaceuticals in development. Biologics include therapeutic proteins, antibody drugs, antibody-drug conjugates (ADCs), vaccines, carbohydrates drugs, blood and tissue-derived pharmaceuticals, gene therapies, even live cells and tissues...
15 April 2017 | By Kevin L Williams (Hyglos GmbH a BioMerieux company)
Presented here are recommendations for performing an endotoxin masking hold-time study. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have requested hold-time studies to determine the presence of what has been called ‘low endotoxin recovery’ (LER) for submission with biologic licence applications (BLA)...
13 April 2017 | By European Pharmaceutical Review
Read the free-to-view digital version of the latest issue of European Pharmaceutical Review...
13 April 2017 | By European Pharmaceutical Review
In this Mass Spectrometry In-Depth Focus: Mass spectrometry in the development of protein biologics; and GC-MS applications in pharmaceuticals analysis...
13 April 2017 | By European Pharmaceutical Review
In this Microbiology In-Depth Focus: Endotoxin masking hold-time study performance parameters; Microbiological monitoring pharmaceutical water systems; The rush to rapid microbiological methods - or not; and an expert view with Charles River Laboratories...
13 April 2017 | By John Norman (Gowling WLG), Patrick Duxbury (Gowling WLG)
Biotech and pharmaceutical firms hold vast amounts of valuable data and information making them prime targets for cyber-attacks – so how are they protecting themselves?
13 April 2017 | By Scott R Rudge (RMC Pharmaceutical Solutions Inc)
Single-use systems have become an important tool in the development and scale up of biotechnology processes. Single-use systems save space, increase flexibility in scale and space planning and, to a large extent, eliminate cleaning costs in development and change over.
13 April 2017 | By European Pharmaceutical Review
FMD and supply chain security; Strategic aspects of change control for pharmaceutical packaging systems; and does the Falsified Medicines Directive lead to a European pack coding guideline?
12 April 2017 | By Alexandra Kibble (Senior Editor - Clarivate Analytics Cortellis)
The annual Drugs to Watch report forecasts that eight new drugs will enter the market in 2017 and achieve blockbuster sales of more than $900 billion by 2021...
10 April 2017 | By Guillaume Roussel, Director of Strategy, Veeva OpenData, Europe, Veeva Systems
Veeva's Guillaume Roussel explains how customer data can create personalised multichannel communication with healthcare professionals in the industry...
4 April 2017 | By Christoph Huwe, Strategic Alliance Manager Therapeutics at Bayer Pharmaceuticals, Global External Innovation & Alliances
Ahead of the 7th Annual Strategic Alliance Management for Pharma conference, we spoke with Bayer's Christoph Huwe about the organisational development of alliance management...
3 April 2017 | By Dr David Pugh, IDTechEx
The latest 2017 pipelines explores new emerging methods of glucose monitoring, analysing these technologies in the new report from IDTechEx Research...
30 March 2017 | By Pasi Kemppainen, Executive Consultant, Pharma Serialisation and Traceability
Pharma serialisation expert, Pasi Kemppainen, gives us his insights on how serialisation reconciliation can ensure product integrity and patient safety...
29 March 2017 | By Niamh Marriott, Junior Editor
We caught up with the CEO & CSO of Panacea for the latest on vaccine immunotherapies - "As a scientist, as long as you are observant and persistent, you may come up with breakthrough discoveries"
28 March 2017 | By Robert Groebel, Vice President of global medical strategy, Veeva
Veeva's Robert Groebel lays out the best practices toward a more coordinated, better healthcare stakeholder experience...
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