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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 Autònoma de Barcelona’s Francesc Gòdia 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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Recipharm and Laccure agree commercial collaboration
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White Papers |
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Recommendations for Implementing Assessment Criteria Guidelines in Lymphoma and Chronic Lymphocytic Leukemia Clinical Trials
Perceptive Informatics
Standardized assessment criteria are becoming increasingly important in obtaining valid outcomes in oncology clinical trials. While standardized criteria encourage a more uniform approach to assessing clinical trial data, they are often subject to the interpretation of the user. These differences in interpretation, while seemingly minor, can have a major impact on assessments. The most commonly used standardized criteria for lymphoma have been no exception. Differences such as minimum new lesion size, lymph node normalization size requirements, inclusion of extranodal lesions and assessment of organomegaly can have a profound effect on overall response. Additionally, heightened scrutiny of the assessment criteria used in a given protocol can lead to questions about a drug’s efficacy if not applied correctly according to regulators’ interpretation.
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Industry Events |
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Pharmaceutical Microbiology East Coast
13-14 November 2017, Renaissance Woodbridge Hotel, New Jersey
Drawing on from the huge success of SMi’s Pharmaceutical Microbiology event series, SMi is delighted to announce the launch of Pharmaceutical Microbiology East Coast. Being the eighth in its series, this event will take place in New Jersey, USA, on November 13th and 14th 2017. Aimed at Microbiologists, Quality Control and Quality Assurance Managers, Pharmaceutical Microbiology East Coast 2017 will address the best practices for rapid microbial and sterility testing and tackle the challenges of contamination control.
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