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| home > ebr > Autumn 2014 |
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 PUBLICATIONS |
European Biopharmaceutical Review |
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Editor’s Letter
Deborah O’Neil ponders the recent Ebola outbreak and discusses some of this edition’s focus features.
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Mass Spectrometry
Molecular Weight
Intact mass analysis has the benefits of minimal sample preparation, high-speed analysis and minor method-induced modifications. Nicholas Michael and Pat Easton at Reading Scientific Services Ltd explain.
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Column Technology
HPLC’s Golden Jubilee: Part 2
In the second of a two-part series, Ronald Majors from Agilent Technologies reviews the progress of highperformance liquid chromatography over the last 50 years and considers what the future holds.
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Nanotechnology
On Target
A sound understanding of biological responses, combined with close coordination of drug delivery mechanisms and particle toxicology, are essential for the safe and effective use of nanoparticles in drug delivery, advises Aiswariya Chidambaram at Frost & Sullivan.
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Transient Gene Expression
Shifting the Balance
Stable cell line generation can be costly in terms of time, labour and money. Karen Donato, Krista Steger and Meg Duskin at MaxCyte, Inc weigh up transient gene expression as an alternative.
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Q&A: Cell Line Development
Path to Progress
FUJIFILM Diosynth Biotechnologies’ Alison Porter tells EBR what must be considered when creating a new host cell line, and gives tips on how to save future development time and meet production requirements.
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Mammalian Cell Culture
Testing Times
Universitat Autňnoma de Barcelona’s Francesc Gňdia recommends the design of experiments approach as a means to accelerate the screening of effi cient compounds and the corresponding optimal conditions.
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Regulatory Challenge
Rapid response
The growing advances in genomics and how this area fi ts in with personalised medicine is uncharted territory, particularly for regulatory agencies. Regina Au at BioMarketing Insight contemplates the current approval processes.
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Personalised Medicine
Individual Focus
With molecular profi ling allowing for patient-specific therapeutic strategies, the need to encourage research must be balanced against demands for privacy protection, reports Emma Naks at EBR.
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EU Legislation
In Harmony?
Shuna Mason from CMS points out that although recent legislative changes reveal an intention to promote personalised medicine within the EU, there is still some way to go in harmonising regulation.
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Temperature Standardisation
Playing it Cool
Rolf Ehrhardt and Maria Thompson from BioCision raise awareness of the importance of temperature standardisation in the field of cell biology, and evaluate current practice.
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Industry Insight
Hot Spot
EBR talks to Frédéric Druck at BioWin about Wallonia, Belgium, and why this region is proving a favourite for companies looking to focus on immunology R&D.
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In Brief
A Tale of Two Cities
Despite their common heritage, the US and UK have evolved two distinct approaches to the provision of healthcare and managing costs on a national scale. Emile Bellot explores further.
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Industry Collaboration
Better Together
Pharma companies must realise that productivity does not exist only in delivering effective new compounds, but also in playing a responsive and active part alongside others, reason Peter Wagner and Christoph Schnorr of Quintiles.
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Open Innovation
Compound Interest
Simon MacKenzie and Sylviane Boucharens at BioAscent Discovery Ltd suggest why using corporate compound collections as a shareable asset is both promising and valuable.
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Clinical Supply Partnerships
Need for Speed
Martin Lamb and Claudia Williams at Biotec Services International propose partnering with a clinical supply business to help cut costs and reduce time to market.
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Drug Development
Eye for Success
MPI Research’s Scott Haller believes that contemporary molecular imaging offers pharma a set of tools capable of dramatically de-risking clinical drug development.
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Kinetic Modelling
Made to Measure
When it comes to oncology imaging, volumes can allow for a more complete picture, as well as a sophisticated estimation of tumour growth. David Raunig, Gregory Goldmacher and Stephanie Owens at ICON reflect.
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News and Press Releases |
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Quanticate Partners with CluePoints to Offer Data Quality Oversight capabilities
Quanticate, a data-focused clinical research organisation (CRO), has announced that it has partnered with CluePoints as part of its new Data Quality Oversight service.
More info >> |
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White Papers |
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The Flexible Factory Concept: A flexible bioprocessing platform to meet the changing needs of biomanufacturing
GE Healthcare Life Sciences
For the past several years, the biopharma industry has been buffeted by
dynamic market conditions that are rapidly reshaping manufacturing
requirements. These factors include:
• The rise of small-market pharmaceuticals that do not require the production scale of the previous “blockbuster” drug model
• Increased titers and process productivity that generate more bulk-product within a much smaller manufacturing footprint
• The emergence of biosimilars and continued evolution of healthcare
reform, which will increasingly pressure drug pricing and require
greater cost discipline
• Greater competition and shorter patent protection timelines, which will further ratchet up time-to-market pressures
• Tighter capital markets that will create heightened scrutiny for all new investment projects
More info >> |
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Industry Events |
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10th Annual Summit for Clinical Ops Executives
18-21 February 2019, Hyatt Regency Orlando, Florida
Celebrating its 10th successful year, SCOPE Summit 2019 takes place
February 18-21 in Orlando, FL. Over the course of four stimulating days of
in-depth discussions in 19 different conferences, 3 plenary keynote sessions,
and the ever-popular interactive breakout discussions, the programming focuses
on advances and innovative solutions in all aspects of clinical trial planning,
management and operations, including...
More info >> |
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