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| home > ebr > Autumn 2015 |
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 PUBLICATIONS |
European Biopharmaceutical Review |
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Editor’s Letter
Deborah O’Neil picks out a few of this edition’s focus features and comments on the need to balance market protection for the originators of novel therapies against wider healthcare access to biosimilar alternatives.
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MicroScale Thermophoresis
Method of Choice
2bind’s Thomas Schubert explores the wide application of MicroScale Thermophoresis – a novel technology that can be used to analyse the binding parameters of molecular interactions. Being fast and fl exible, it can help researchers in antibody characterisation and epigenetics.
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ADCC Assays
As Easy as ADCC
With many drug developers turning to ADCC assays to help get the measure of biosimilarity, Andy Upsall of BioOutsource recommends that scientists be prepared to use an orthogonal approach to better understand the therapeutic and how it fi ts with the clinical outcome.
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Biosimilar Analysis
Compare and Contrast
Responding to regulations governing the quality of biosimilars, BioPharmaSpec’s Andrew Reason and Howard Morris contemplate the range of analytical techniques on offer to prove the integrity of an active pharmaceutical ingredient following purification.
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Regulatory Spotlight
Western Influence
Despite following the EMA’s lead and adopting a stepwise comparability approach, Nick Beckett and Jane Lin at CMS believe that China still has some way to go before its biosimilar regulations can be brought in line with international practice.
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Industry Insight
The Power to Defeat Dementia
In his interview with EBR, Eric Karran from Alzheimer’s Research UK answers questions on the role of the Dementia Consortium and how it plans to bring together partners from both industry and academia.
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In Brief
A Banner Year for Biopharma
Industry advisor Emile Bellott reflects on biopharma’s recent highs, praising the successes of 2014 and thinking ahead to what the coming months – and following years – may bring.
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Market Focus: Biosimilars
Window of Opportunity
Molekule Consulting’s David Alderman thinks about life after the patent cliff. Although the biosimilar opportunity is robust and growing, market factors – including a lack of consumer knowledge, fierce competition and innovator companies' desire to defend their biologic assets – could mean that uptake is slow.
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Toxicity Studies Don’t Forget the Kids
Traditionally considered an offshoot of reproduction
toxicology, juvenile animal studies are emerging as a field in their own right. Sequani’s Emily Richmond looks into this area, which could lead to better
researched and intelligently developed medicines for children. |
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Vaccine Development
Heal the World
As initial projects launch with rotavirus and HIV, it is only a matter of time before old prophylactic vaccines are finally replaced with innovative mRNA alternatives. CureVac’s Ingmar Hoerr investigates the many advantages of this new method of disease prevention.
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Genetically Engineered ADCs
Making Sense From Nonsense
Feng Tian at Ambrx examines how site-specific ADC technologies offer a new starting point for the rational design of drugs with optimised therapeutic windows. In particular, genetically engineered ADCs are well-positioned to improve targeted drug delivery.
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Alzheimer's Disease
Brain Power
Hamish McDougall and Peter Murphy of BioPharm Insight report on the latest therapeutic approaches currently under development for Alzheimer’s disease. It may be a huge unmet medical need, but there is much debate on the appropriate drug combinations and mechanisms to target.
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News and Press Releases |
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ISO 45001: Global occupational safety and health are important to Gerresheimer
Düsseldorf, June 30,2020: The Gerresheimer Group has declared DIN EN ISO 45001 to be the mandatory global standard for all its plants. It replaces thepreviously applicable standard OHSAS 18001in the field of occupational health and safety.
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White Papers |
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Medpace Reference Laboratories establishes state of the art Flow Cytometry techniques for flexible approaches to clinical trials across multiple therapeutic areas.
Medpace
Cytometry is the process of measuring the properties of individual cells. These properties may include gene or protein expression, chemical properties, deoxyribonucleic acid (DNA) content, and various cellular functions. The earliest methods of cytometry relied upon light microscopy for the classification and observation of cells and cellular components. Microscopy permitted direct visual observation of cells for the first time, leading to the classification of cells by morphology and insight into cellular functions. However, the time required for microscopic analysis constrains the number of samples or number of cells in each sample that can be examined. Therefore, the utility of microscopy for analysis of rare cells or in situations where sample throughput is a priority is limited. Flow cytometry was developed largely to improve upon these limitations.
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Industry Events |
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Formulation and Drug Delivery Series UK
8-9 July 2020, Oxford Global
This event brings together leading formulation, drug delivery and biologics manufacturing experts from around the world across two days. The panel of prominent industry leaders and world-leading scientists will share the latest case studies, innovative developments for novel therapeutic products and strategies for drug development.
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