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European Biopharmaceutical Review

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Autumn 2011
   
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BioBusiness, Finance & Communication

Prepared to Launch

Mike Rea at IDEA Pharma considers the importance of product lifecycle decisions and explains how assessing commercial and regulatory risk, in addition to considerations of investment and time-to-market, can lead to a strong competitive advantage.

 
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App Potential

As the internet promotes customer satisfaction by encouraging feedback via online publications, the importance of maintaining a web presence is growing. Kelly Sladek at SCORR Marketing outlines the inevitable evolution of online promotions.

 
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Digital Exchange

A recent survey demonstrates an increasing dependence on electronic communication media within the biotech sector. Linda Bowers at IntraLinks evaluates the implementation of web-based document exchange solutions.

 
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BioFinance and Management

Trimming the Fat

Lean Six Sigma has been proven to be an effective and helpful tool for contract laboratories providing biopharmaceutical analysis. Melanie Dippel at Charles River Biopharmaceutical Services GmbH looks at benefi cial collaborations with an outsourcing partner.

 
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BioBusiness Development

The Biotechisation of Pharma

With the noticeable rise of ‘biotechisation’ in pharma companies in recent years, Flavia Botschen and Markus Thunecke at Catenion look at how this will affect all related branches of the densely interwoven biopharmaceutical industry.


 
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Discovery Technology

Protein Production

Igor A Kaltashov at the University of Massachusetts-Amherst assesses the advantages and challenges of mass spectrometry-based methods used for characterising protein as well as its broader impact on the production process.

 
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BioDiscovery

Flow Cytometry Outsourcing

Carla G Hill and Thomas W McCloskey at ICON Central Laboratories report on how the use of flow cytometry for clinical trial testing is set to increase, as accurate evaluation of cell-based biomarker assays becomes a necessity in the assessment of biologic drug candidates.

 
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BioDevelopment

Cause and Effect

Biomarkers are integral to improved diagnostics and novel therapeutics. Ioannis Amarantos, Thomas Laufer and Thomas Brefort at febit biomed GmbH study their four primary categories of application and discuss research case studies of miRNA development.

 
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Legal, Regulatory and Public Policy

Regulatory Challenges

The Survey Says

Alan Trounson and Elona Baum at the California Institute for Regenerative Medicine (CIRM) run through their research on current perspectives regarding regulatory uncertainty when facing challenges for commercialisation in the fi eld of regenerative medicine.

 
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Biodevelopment and Manufacturing

Single-Use Technology

At Your Disposal

Nicole O’Brien at Gallus BioPharmaceuticals discovers that the road to a fully disposable biomanufacturing process – from bench to commercial production – is just on the horizon, and offers an insight into how it is transforming biotherapeutics.

 
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BioFormulation and Manufacturing

Peptide Synthesis

Building Bonds

In-depth knowledge of peptide production methods to optimise yield and purity is critical to faster and more cost-effective commercialisation of peptidebased therapies, elaborates Gary Hu at the American Peptide Company.

 
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BioManufacturing

Drawn to Scale

Successful manufacturing of biopharmaceuticals relies on good process design, scale up and control strategies. Graham McCreath and Mahesh Shivhare at Fujifilm Diosynth Biotechnologies demonstrate the possibilities that small scale fermentation can offer.


 
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CANCER FOCUS

Setting Your Sites

While there are numerous challenges for the effective contact research management of most clinical trials, oncology studies pose even further complications. Erin Anderson and Daryl Ann Fallon of Premier Research Group Limited focus on the goals and objectives the biotechnology sector face today.

 
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Peptide Potential

Citing recent research into the potential of a synthetic peptide known as ‘p28’, Tapas K Das Gupta, David R Volk and Craig W Beattie at CDG Therapeutics, Inc relate how new findings on this peptide could alter future cancer therapies.

 
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APPLIED RESEARCH, DEVELOPMENT AND PRODUCTION

Express Delivery

siRNAs have proved their capacity to perform in a wide range of applications, from human diseases to plant pathogen resistance. Kathleen Hefferon at the University of Toronto explains how their development has been adapted within the medicinal and agricultural fi elds.

 
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REGIONAL UPDATES

The Future’s Orange

Annemiek Verkamman at Life Sciences Health looks at the social, technological and sector trends within the Dutch life sciences industry as these companies compete to be global players.


 
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Edited by
Dr Deborah O'Neil,
Chief Executive and Scientific Officer,
NovaBiotics Ltd
Published quarterly in
January, April,
July and October

News and Press Releases

POP TEST ADDRESSES THE PROBLEM OF UNRELIABLE DATA FROM CONTINUOUS GLUCOSE MONITORS

A major insight relating to the unreliability of data from continuous glucose monitors was published in the Nature journal, “Scientific Reports”, by Neil Theise, MD., the Lead Scientist of Pop Test, LLC and colleagues. The discovery of the “Interstitium”, a newfound human organ, by Dr. Theise and his collaborators, can be viewed by using the link https://www.nature.com/articles/s41598-018-23062-6 Continual glucose monitoring via an indwelling cutaneous needle measuring glucose in interstitial fluid (now identified to be in the “interstitium”) has been a game changer in the treatment of type 1 diabetes mellitus because of its accuracy. However, the needles used to collect this glucose containing fluid often fail in as little as a week. Despite the reliance on fluid from this space, the microanatomy of the interstitium has never been defined. The sensors currently in use were developed with the presumption of interstitial fluid being located somewhere in the sub-epidermal layers of the skin, but the actual anatomy relating to needle placement was always unclear.
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White Papers

What is process characterization?

EXPUTEC

Process characterization is an essential step in the commercialization of a new (biological) drug. For drug product commercialization, manufacturers must validate the drug’s manufacturing process. This ensures that the manufacturing process delivers consistently a quality product and that the patient is not at risk.
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Industry Events

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.
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