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European Biopharmaceutical Review

ebr
Spring 2014

   
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Editor’s Letter

Promising developments are springing up across biopharma – Deborah O’Neil outlines some of the advances in R&D and biotechnology that emerge in this edition.
 
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BioResearch and Innovation
Cell-Based Therapies

Back to the Future


They may be an emerging niche within biopharma, but cell-based therapies are enjoying a steep growth trajectory. R Lee Buckler at Cell Therapy Group, and BioCision’s Rolf Ehrhardt and Maria Thompson outline the new technologies in this area.
 
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Regenerative Medicine

A New Dimension


As we enter a new pluripotent era of stem cell research, scientists are starting to take advantage of 3D printing technology to produce customised, cutting-edge prosthetics. Regina Au from BioMarketing Insight welcomes the revolution and predicts an exciting future.
 
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Culturing Cells

Controlled Environment


Sample security, culture efficiency and minimising contamination risk are essential when it comes to culturing cells. Jacqueline van der Zijden of Panasonic Biomedical describes how advances are helping to ensure reliability in the lab.
 
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BioDevelopment
Inter-Species Safety

Advancing Xenogeneic Therapy

Peter Gaskin and Kathryn Parsley from PPD examine the growing body of work on the non-clinical testing strategies for xenogeneic products, enabling the safe progression of products from animal models into clinical studies.

 
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Neutron Crystallography

In the Spotlight


Matthew Blakeley from the Institut Laue-Langevin explores how the combined use of X-rays and neutron crystallography is well-suited to drug development, as a recent study of interactions between a common clinical inhibitor and HIV-1 protease demonstrates.
 
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Legal, Regulatory and Public Policy
Controlled Substances

Chemical Weapons

Cheminformatics applications now being developed can aid researchers in complying with the global plethora of controlled substances regulations. Aurora Costache and Krisztian Niesz at ChemAxon set out some of the features and functionalities.
 
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THERAPEUTICS FOCUS - VACCINES AND INFECTIOUS DISEASES
Vaccine Production

Taking the Strain


The rapidly expanding demand for vaccine products for viral diseases such as rabies has prompted more sophisticated production techniques based around cell culture systems. K John Morrow, Jr, at Newport Biotech and Ma Sha at Eppendorf, Inc explain.
 
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BioManufacturing
Early-Phase Manufacturing

Fast and Flexible

To ensure Phase 1 oral solid dosage formulations are fit for purpose, early-stage manufacturers need approaches that are quick, adaptable and appropriate to the API in question. Jon Sutch at Patheon considers the systems needed.

 
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Protein Therapeutics

Flexibility in Bioprocessing

Adaptability is the name of the game in bioprocessing, with advances in cell culture, equipment, separation technologies and plastics applications enabling great strides in the production of a broad range of protein therapeutics, says Michiel E Ultee of Gallus BioPharmaceuticals.
 
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CANCER FOCUS
Antibody Engineering

Next-Generation ADCs

As we learn more about antibody drug conjugates, one of the key features for clinical success – and regulatory approval – will be the ability to control the conjugation process to optimise efficacy and safety, as well as to reduce toxicity risk, comments Neil Butt at PolyTherics.
 
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Tumour Modelling

Imaging of Relevance

The blending of developments in tumour models and imaging technologies is enabling efficient and robust use of the most clinically relevant and predictive models, argue Dick Leopold and Patrick McConville of Molecular Imaging, Inc.
 
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HPV-Related Cancers

Infection Control

With more HIV-positive individuals facing a growing risk of HPV-related cancers, Eyal Talor at CEL-SCI Corporation stresses the need for further research, such as a recent study looking at immunotherapy against AIN in co-infected subjects.
 
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REGIONAL UPDATES
Regional Development: Russia

Home Advantage


In a bid to reverse its reliance on imported pharmaceutical products, Russia is boosting the domestic development and manufacturing of innovative drugs through homegrown start-ups and investment. Maria Bomer from Bomer Pharma Consultancy explains.
 
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In Brief

Follow the Money

Emile Bellott explores the rising tide of biomedical R&D in East Asia – and how it may impact future generations of biotech companies.
 
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INTERVIEW
Industry Interview

Human Impact


Octapharma’s Stefan Wietek talks to EBR about the intricacies of developing human proteins and the global demands facing the plasma industry.
 
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BUSINESS STRATEGY
Bioclusters

Group Dynamics


Many small and medium enterprises in the biopharma space are working in clusters to exploit the benefits of a supportive business ecosystem. CEBR’s Claire Skentelbery, Fabrizio Conicella at Bioindustry Park Silvano Fumero and BioWin’s Frédéric Druck report.
 
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Biotech Investment

Going Public


2013 was the most active year so far for initial public offerings of life sciences companies – and the biotech bonanza is set to continue this year. It can be a great route to success, but Sophie C McGrath of Brown Rudnick urges firms to consider some critical issues before going public.
 
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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

INC Research Expands Clinical Pharmacology Team to Support Early Phase Business Unit

Raleigh, N.C., Feb. 6, 2014 – INC Research, a therapeutically focused global clinical research organization (CRO) with a Trusted Process® for delivering reliable results, today announced the appointment of Beatrice Setnik, PhD, as Vice President, Clinical Pharmacology. Dr. Setnik will support INC Research’s world-class Early Phase Business Unit, providing scientific direction on matters related to abuse liability.
More info >>

White Papers

Working Towards a Standardised Identification Solution

Packaging Coordinators, Inc.

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

European BioNetworks Summit

7-8 July 2014, Marriott Hotel Regents Park, London, UK

As many products come off patent, this is causing ‘game-changing' falls in revenues. Consequently, industry is grappling with questions pertaining to the most effective strategies for developing meaningful new drugs and how it should collectively fund and reward their discovery and development activities.
More info >>

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