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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

Nemera organized an expert review on the present and future of inhalation products

“Connectivity in every new inhalation device?” This topic was one of those discussed with different inhalation experts - Manfred Keller, Pascal Cavaillon and Henry Chrystyn – during a round table organized by Nemera in Paris to review the advantages and limitations of inhalation devices.
More info >>

White Papers

Orthogonal Approaches for the Analysis of Protein Sequence and Post Translational Modifications of a Monoclonal Antibody

RSSL

Monoclonal antibodies are an important class of biopharmaceuticals. They are expressed from living cells and therefore, are subject to complex biochemical pathways. Not all of these pathways are fully understood and many are known to be sensitive to subtle environmental changes during production. These changes may affect the final biopharmaceutical sequence, structure and post-translational modifications. This is in addition to any changes that may occur during subsequent purification. This means that the final product from one batch may be subtly different from another batch. Furthermore, each batch is a heterogeneous mix of similar molecules. Analysis of the degree of batch-tobatch variation, and batch heterogeneity, is therefore, very important to establish in order to be confident that the drug is safe and effective for medicinal use.
More info >>

Industry Events

World Advanced Therapies & Regenerative Medicine Congress 2019

15-17 May 2019, Business Design Centre, London

The World Advanced Therapies & Regenerative Medicine Congress is an exhibition and conference that has grown to become one of the best and most established cell and gene events in the world today.     The 2019 edition will be in its 14th year and it continues to grow and attract a large audience of biotech, pharma, start-ups, investors, research and technology companies from around the world. The conference and exhibition will host over 1000 attendees, 250 speakers and 80 exhibition booths. Over 500 different global companies are represented every year at this event. 
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