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European Biopharmaceutical Review

ebr
Winter 2018

   
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Editor’s Letter
 
EBR Editor Dr Deborah O’Neil offers a summary of the issue’s contents and comments on the recent breakthrough in treating Huntington’s disease.
 
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BioResearch and Innovation
Novel Therapies and Pneumococcal Pneumonia
 
Back to the Future
 
Jonas Elliott Gerson, Dr Donald Gerson and Allison Turner at PnuVax SL Biopharmaceuticals detail how pneumococcal pneumonia could be cured in the developing world and the ways in which immunotherapeutic approaches can decrease antimicrobial resistance.
 
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Resistance Rates
 
Situation Critical
 
AMR Centre’s Dr Peter Jackson argues for a greater effort to combat antimicrobial resistance – a serious menace to public health that contributes to over 700,000 deaths globally.
 
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Antiseptics and Antibiotics
 
Fight Against Resistance
 
Antimicrobial resistance in humans and animals is raised through improper use of antibiotics or not controlling infection well enough. Dr Michele Barbour at Pertinax Pharma believes behavioural science should be employed
 
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Competency-Based Training
 
Training Day
 
Dr John Milne at the National Institute for Bioprocessing Research and Training demonstrates how competency-based training will be pivotal to improving the work of staff, with the rise of new types of product and manufacturing processes.
 
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Discovery Technology
Strategies to Mitigate Risk
 
Constant Vigilance
 
Tony Clarke at ICON delves into how anticipating risk management and ensuring safe design when employing connected medical devices during product lifecycles can lower financial and medical risks.
 
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BioDiscovery
New Treatments
 
Bridging the Gap
 
Dr Gregory R Stewart at Pairnomix posits, by way of a case study, that today’s advancements in genetics can reduce the delay between gene discovery and its use in real world treatments.


 
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BioDevelopment
Contamination Risk Management Strategies for ATMPs
 
Keeping It Clean
 
With the viral safety of biological medicinal products in regenerative medicine being essential, well-characterised cell banks can help avoid contamination and maintain quality, as Andy Bailey at ViruSure notes.
 
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Biodevelopment and Manufacturing
Patient Safety
 
Warning Letters
 
An unusual amount of warning letters issued by the FDA show that the manufacturing process is being increasingly monitored, as discussed by Søren Lund Kristensen and Dr Harm Otten at Particle Analytical.
 
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THERAPEUTICS FOCUS - VACCINES AND INFECTIOUS DISEASES
VLP-Based Polio Vaccine
 
Particle Acceleration
 
Methods employed in cryo-electron microscopy help to characterise the structure of new polio vaccines, as outlined by Professor Dave Stuart at Diamond Light Source.
 
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Lifesaving New Vaccines

Gut Feeling
 
Björn Sjöstrand at Scandinavian Biopharma details how new vaccines are being tested in clinical trials to combat the virulence of Enterotoxigenic Escherichia coli in the developing world.
 
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Drug Discovery
Sophisticated Drug Development
 
Under Lock and Key
 
Dr Misha Kapushesky at Genestack warns that, to maintain their integrity, a higher level of sophistication is needed in data management systems, especially as drug development agreements become more popular.

 
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Collaborating in Data Management
 
Discovery Decisions
 
To guarantee good data management, software creators must collaborate as much as possible with project leaders and decision makers to give them easy access to data. Dr Matthew Segall and Dr Chris Leeding at Optibrium explain.

 
 
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LICENSING AND REGULATORY
Q&A: Data Compliance
 
Utmost Integrity


EBR
asks Darren Barrington-Light at Thermo Fisher Scientific and Brian Alliston at Sterling Pharma Solutions to elaborate on the ways to achieve data integrity compliance using chromatography data systems.
 
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Global Compliance
 
Regional Requirements
 
Life sciences companies are making the most of globalisation and the standardisation of submission requirements. Key differences remain in regulatory needs between regions, as argued by Kimty Bui-Van at ProductLife Group.
 
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CELL-BASED RESEARCH
Three-dimensional Cell Culture
 
Cell-ebration
 
Professor Fredrik Johansson at Lund University and Maximilian Ottosson at Cellevate look over the systems utilised when researching three-dimensional cell culture.



 
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Edited by
Dr Deborah O'Neil,
Chief Executive and Scientific Officer,
NovaBiotics Ltd
Published quarterly in
January, April,
July, and October

News and Press Releases

PCI Pharma Services Completes Acquisition of Sherpa Clinical Packaging

Philadelphia, USA – October 2, 2018 Leading global biopharmaceutical outsourcing services provider PCI Pharma Services (PCI) has announced the completion of its acquisition of Sherpa Clinical Packaging (Sherpa).
More info >>

White Papers

Maximize the ROI of Your Post-Approval Research

Bioclinica

Expenditures in post-approval (Phase IV) research are going up across the pharmaceutical, biotech and medical device industries. Given the resources you’ve committed to post-approval research, you may be wondering if you’re getting the greatest possible return on your investment. Discover how to harness the power of post-approval research to increase data collection, reduce resource burn, save money, and maximize your ROI!
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Industry Events

PDA Universe of Pre-Filled Syringes and Injection Devices

8 October - 9 November 2018, Loews Royal Pacific, Orlando, FL

At the 2018 PDA Universe of Pre-filled Syringes and Injection Devices,industry and regulatory experts will share experiences, new developments, regulatory considerations, challenges, and industry trends and best practices. This is a must-attend event for all industry professionals involved in the development, manufacturing, testing, or marketing of pre-filled syringes and injection devices.
More info >>

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