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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

Make a Clean Sweep with Teknomek’s New Anti-bacterial Cleaning Range

Teknomek has introduced a new range of anti-microbial cleaning tools designed to minimise risk in labs and cleanroom environments by reducing the potential for cross-contamination. The new products include brooms, deck scrubs, squeegees, scrapers, spades and buckets, all are available in a choice of five colours to support area segregation.
More info >>

White Papers

New Temperature Profiles from a Global Study

Laminar Medica

Recently there has been an influx of temperature mapping studies to collect sufficient ambient data to develop temperature profiles.  Solid temperature profiles on specific shipping routes are required to ensure streamlined packaging and robust lane qualification. The most reliable method to develop temperature profiles is to capture the actual reading from shipments, as well as using the historical and meteorological data to increase the confidence level.
More info >>

Industry Events

RDD Asia 2018

14-15 November 2018, Grand Hyatt Kochi, Kerala, India

A must-attend meeting for pulmonary and nasal researchers, inhaled product developers and vendors active in this important pharmaceutical niche.
More info >>

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