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European Biopharmaceutical Review

ebr
Summer 2017

   
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Editor's Letter

Editor’s Letter


Offering an overview of this issue, EBR Editor Dr Deborah O’Neil covers the problems facing creators of rare disease treatments and the ongoing debate surrounding genetic engineering.
 
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Science and Innovation
Therapies for Blood Cells

Upcycling Genomics


Dr Franziska C Ruf at SIRION Biotech suggests that advances in the gene therapy sector, using hematopoietic and stem cells, will lead to a cure to heritable diseases, such as asthma, arthritis and cancer.
 
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Oligonucleotides and Separation

Complex Characters

Characterising oligonucleotides is a process fraught with analytical challenges, but it is showing positive results in clinical trials and continues to gain traction within biopharma organisations, says Jon S Kauffman at Eurofins Lancaster Laboratories.
 
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BioDiscovery
Achievements in Protein Manufacture

What about Pichia?

Advances that remedy current recombinant protein expression problems are exposing one yeast as a more efficient system for manufacturing therapeutics, reveal Thomas Purkarthofer, Iskandar Dib and Evelyn Trummer-Gödl at VTU Technology.
 
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Pharmaceutical Stability

Protein Productivity


Lisa Newey-Keane
at Malvern Instruments proposes that analytical tools for evaluating stability, such as the latest DSC instruments, could help scientists gather important information with greater efficiency and accelerate liquid formulation.
 
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Legal, Ethical and Regulatory
Orphan Disease Legislation

Acting Up


The Orphan Drug Act might require updating, stress Matthew Weinberg and Emily Krulewitz at The Weinberg Group, as its efficacy continues to be debated and a lack of clear-cut distinctions are allowing some to cheat the system.
 
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Q&A: Rare Disease Dilemma

Sustainable Solutions


In this interview, Hege Hellström at Sobi EMENAR and Neil Dugdale at Sobi UK and RoI explain why a long-term approach to the treatment of rare diseases is key and discuss why the company advocates collaboration with stakeholders.
 
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Gene-Editing

Cut and Paste


The science fiction-like concept of gene-editing faces a barrage of ethical concern from parties across the industry as well as wider fields, but Jimmy Muchechetere at Investec Wealth & Investment believes it is an opportunity that could transform pharma.
 
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Focus on Pharmacovigilance

Strategic Advantage

ProductLife Group
’s Cheryl Key determines that maintaining investment in pharmacovigilance processes has become more significant following the escalation of globalisation and resulting heightened business demands.
 
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In Brief

In Your Genes


EBR’s Industry Advisor Emile Bellott explores the recent FDA approval of direct-to-consumer genetic testing for a variety of diseases.
 
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THERAPEUTIC DEVELOPMENT
Biosimilars Development

Revolution or Evolution?


The pharma industry does not exist in a vacuum and, as such, the economic and political climate have a substantial impact on the market and manufacturers of biosimilars, according to Guillaume Plane at Merck.
 
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Mature Products

Organisation Optimisation

David Balderson
at Sciformix Corporation acknowledges the opportunities outsourcing offers, as he points out that effectively managing an already established portfolio of products is just as critical as the development of new ones.
 
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Comparability Analysis

Dissecting Structures

BioPharmaSpec's Dr MI Millichip
and Dr AJ Reason argue that biosimilarity assessment guidelines are not sufficiently precise regarding determination of higher order structure. It is necessary for these tests to go hand-in-hand with primary structure characterisation.
 
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Biologic Classification

QbD in Action

Although it can introduce further associated difficulties, Simon Cubbon at Thermo Fisher Scientific advocates the use of high-resolution mass spectrometry within QC and lot release for routine biopharma characterisation.
 
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Personalised Therapeutics

Hidden Treasures


New small molecule biomarkers, which can be discovered through mass spectrometry, could enable a clearer understanding of the precise impacts of medicine and allow drugs to more effectively treat diseases, according to Professor Hermann Mascher at pharm-analyt Labor.
 
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Bioanalytical Technology

Teething Problems


Richard Hucker, Ian James, Scott Vincent
and Carl Watson at A4P Consulting remind us that key decisions need to be made from science, operational and business perspectives throughout the drug development process and the transition to clinical activities.
 
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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

Avacta and Mologic Enter Research and Product Development Collaboration Agreement

Avacta announces the formation of a collaborative research partnership
More info >>

White Papers

Systems Engineering for Complex Portable Medical Device Development

Phillips-Medisize

As the demand for complex, portable medical devices continues to grow, reducing risk and increasing efficiency during the development of these products should be paramount. Taking a systems-engineering (SE) approach to development provides a holistic, organized, and deliberate method for identifying as well as reducing both patient and business risks early in the process. Furthermore, it facilitates efficient progression throughout the entire product development life cycle.
More info >>

Industry Events

Outsourcing in Clinical Trials Medical Devices 2017

27-28 June 2017, Santa Clara, CA

OCT Medical Devices moved to Irvine, California for the first year in 2016, and we are pleased to say it proved a resounding success. As the only event to cater for the Southern California Medical device hub in Irvine, it brought together a variety of medical device companies of all sizes, including Medtronic, Edwards Lifesciences, Onciomed, Inc and St Jude Medical.
More info >>

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