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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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WORLD’S FIRST PCM CARGO COVER
A British team of scientists at TLX Cargo Ltd have invented the worlds Cargo Cover/Thermal blanket that incorporates Phase Change Material (PCM) into it`s structure, solved the problem of hot lane temperature excursions on the tarmac.
More info >> |
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White Papers |
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Working Towards a Standardised Identification Solution
PCI Pharma Services
The security of the pharmaceutical supply chain is an issue of growing concern, with recent reports addressing its vulnerability to counterfeiting. The complexity of the European supply chain is one of the key factors of this counterfeiting pandemic, with millions of medicine packs being moved around the EU, annually. Aside from this, fragmentation has resulted in decreased transparency in the supply chain and increased difficulties to track and trace medicines, leading to significant threat from counterfeiting. As a key source of income for the European economy, it is essential that the supply chain remains safe and free of counterfeits. A significant stumbling block within the industry remains to be the lack of a unified, single‐source pan‐European or indeed global database where scanned bar codes on drug packaging can be verified at point of dispense. At some point in the future the pharmaceutical industry, regulatory bodies, clinicians and retailers will need to join forces to overcome this.
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Industry Events |
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BioProcess International European Summit
23-25 April 2018, RAI, Amsterdam
Bringing together 900+ attendees from all major departments
in bioprocessing: Cell Culture, Downstream, Manufacturing, Vaccines, Viral
Safety and Cell Line Development this April in Amsterdam, Europe’s largest bioprocessing
event BPI Europe 2018 will provide you with the latest advice on how
optimise bioprocessing through connecting science, technology and business.
More info >> |
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