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| home > ebr > Autumn 2017 |
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 PUBLICATIONS |
European Biopharmaceutical Review |
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Editor’s Letter
EBR Editor Dr Deborah O’Neil talks us through the latest innovative breakthroughs in drug discovery and explores the themes and issues covered by each of our contributors.
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Assay Platform Selection
Harnessing Hybrids
ARCINOVA’s Michael Blackburn asks firms to continually question what specifically is being measured and how data quality can be ensured when using hybrid liquid chromatography-mass spectrometry assays for peptides.
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Method Development
Definitive Screening Designs
Dr Srividya Suryanarayana at Cytovance Biologics discusses a recent case study that used a definitive screening design for imaged capillary isoelectric focusing method optimisation, thus gaining high-quality data.
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Regulatory Mycoplasma Testing
Rapid Methods
Nucleic acid amplification techniques are becoming the preferred option for rapid mycoplasma detection, say Professor Renate Rosengarten, Dr Carl-Ulrich Zimmerman and Dr Martina Sauert at Mycoplasma Biosafety Services.
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Basal-Like Breast Cancer
Signal Detection
Dr Partha S Ray and Dr Roberto Fagnani at 3N Diagnostics introduce a new biomarker for a basal-like breast cancer, an elusive disease type previously difficult to discover and diagnose at an early stage.
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DNA Damage and Immune Response
Firing Up
Dr Eileen Parkes at Queen’s University Belfast and Dr Nuala McCabe and Professor Richard Kennedy at Almac Diagnostics highlight the relationship between cancer cell behaviour and DNAdamage activated immune response.
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Transgene Expression
Size Matters
PlasmidFactory’s Tatjana Buchholz, Dr Marco Schmeer and Dr Martin Schleef suggest that using minicircle DNA for transgene expression can help smooth the process by enabling improved nuclear entry.
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Robotic Surgery
Homing In
Gaining ground in treatments for prostate cancer, thereby improving clinical outcomes and cost-efficiency, could cement robotic surgery as an established and valuable therapeutic method, says Dr Andre Faure at Trod Medical.
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Precision Medicines
New Strategy
David Bunton at ReproCELL Europe, Marian McNeil at Stratified Medicine Scotland and Pamela Brankin at Aridhia stress that early identification of genetic factors that influence efficacy in patient subpopulations is key to success.
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Considerations for Automation
Avoiding Data Overload
Peak Analysis and Automation’s Rob Harkness uses a case study to highlight how promptly integrating automation with a flexible data handling package has a positive effect on workflow, raising the yield of high-quality data.
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In Brief
Risk Ratio
Following the recent FDA approval of a cancer immunotherapy drug, Emile Bellott explores the utilisation and successes of CAR-T, nodding to the limitations that still plague such therapeutics.
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Industry Trends
Adapt to Survive
Peter Muller at Schlafender Hase provides an overview of five trends that have dominated the life sciences industry over 2017, encouraging pharma firms to embrace change and inevitable adaptations.
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Patents for Stem Cell Therapies
A Fresh Look
Helen Henderson and Dr Nicholas Jones at Withers & Rogers get to grips with a regulatory update from the European Patent Office that could benefit organisations currently involved in early stage stem cell research.
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Special Feature: GDPR
EU Impact
Jon Weisberg at SAFE-BioPharma Association, Industry Advisor to EBR, gathered expert views on the potential effects of the EU General Data Protection Regulation, which goes live in spring 2018.
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Boosting Cellular Therapies
Enhanced Effects
Dr Christian van den Bos at Mares Ltd offers a new technique to enhance cellular viability, which involves co-application of small molecules that are known to improve survival of cells post-injection.
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Safety Testing
Revamping Regulations
NDA Group’s Dr Paula Salmikangas argues that the safety information currently required for the clinical development of stem cell products is unclear and may require serious review to improve access to innovative therapies.
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Predicting P450 Metabolism
Driving Discovery
As well as outlining the state-of-the-art of computational approaches for predicting P450 metabolism, Matthew Segall at Optibrium Ltd identifies areas for future development.
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The Future of Organoids
Unleashing 3D
For Dr Colin Sanctuary at QGel, the breakthrough innovation of synthetically specialised extracellular matrixes will transform the use of organoids as a model for human disease and unlock unique possibilities for personalised medicine.
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Discovering New Medicines
Invaluable Influences
Collaboration between CROs and biotechnology firms is crucial for the discovery of new drugs, but Dr Richard Weaver FRSC at XenoGesis Ltd suggests success will also depend on the influence of drug metabolism and pharmacokinetics.
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News and Press Releases |
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Protagen Protein Services expands analytical Service Spectrum in Biosimilar Development Support
Heilbronn/Dortmund February 2019: The success or failure of the development of a biopharmaceutical product is also governed by protein stability. Protein stability is considered a critical parameter during manufacturing, production, formulation, long term storage, efficacy, and delivery to patients.
To meet our customer demands now and in the future, PPS always invests in new analytical technique and recently added a new Differential Scanning Calorimetry (DSC) device.
More info >> |
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White Papers |
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Sourcing Commercial Drugs for Clinical Trials: US vs. EU Understanding the Differences
Myoderm
Sourcing commercial drugs for clinical trials is a dynamic process. There are many factors to consider: single source or regional sourcing, strategy, price, supply availability, lead times, and documentation are just a few. In the past, there were fewer clinical trials that required commercial drug sourcing, so demand was not as high. Today, the demand for commercial drugs in clinical trials has greatly increased and, as a result, inventory is tighter, orders are monitored more closely by manufacturers, and lead times have increased. This report highlights the key differences in sourcing from the US and EU.
More info >> |
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Industry Events |
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Highly Potent Active Pharmaceutical Ingredients (HPAPI)
13-14 May 2019, Copthorne Tara Hotel, London, UK
SMi is delighted to announce its 3rd Annual Highly Potent
Active Pharmaceutical Ingredients conference coming to London on the 13th-14th
May 2019.
The HPAPI global market has developed rapidly in the past
year and is continuing to expand into the future, with over a quarter of drugs
in development worldwide being classified as highly potent. As a result, there
is a growing demand for both pharmaceutical and contracted manufacturers to
adapt to the evolving HPAPI landscape.
More info >> |
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