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European Biopharmaceutical Review

ebr
Summer 2018

   
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Editor’s Letter

EBR Editor Dr Deborah O’Neil details the history of diabetes treatments and how they have changed over the last eight decades, while also summarising the themes covered by the issue’s authors.
 
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Science and Innovation
In Brief

Natural Intelligence Looks at AI

EBR's Industry Advisor, Emile Bellott, assesses how the biopharmaceutical industry and human health can benefit from the use of artificial intelligence.
 
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PATENTING POLICY AND PRACTICE
Considerations for Protecting and Launching Biosimilars

Patenting Biosimilars

A streamlined process is enabling generics companies to enter the market with a biosimilar product and gain approval quicker than ever before, as explained by Jennifer O’Farrell at Boult Wade Tennant.
 
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Biosimilar Applications

The Patent Dance

Sanya Sukduang and Thomas J Sullivan at Finnegan detail how biosimilar applicants can now bypass the usual lengthy information exchange after the introduction of new biologics licensing rules.
 
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Mass Spectrometry
Primary Sequence Analysis

Understanding Biosimilars

Amino acid sequencing relies on state-of-the-art technology to deliver the best possible analytics, though the mass spectrometry involved can be problematic, as discussed by Dr Richard Easton and Dr Andrew Reason at BioPharmaSpec.
 
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Monitoring with Mass Spectrometry

Driving Discovery

EBR asked Dr Simon Cubbon at Thermo Fisher Scientific about the benefits of using a mass spectrometry-based multi-attribute method in drug development.
 
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Probing Pathology with MALDI

Visualising Alzheimer’s

Dr Shannon Cornett at Bruker Daltonics suggests the ways in which ultra-high resolution mass
spectrometry imaging techniques can be advantageous in understanding neurological disorders.
 
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Orphan Drugs
Gene Therapy

End of the Tunnel

Dr Serge Braun at AFM-Téléthon examines the ever-changing climate of gene therapy technologies and how they are applied and outlines the limitations that they may present.
 
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Analytical Tools
Monoclonal Antibody Innovations

Enhancing Analysis

A growing need for rapid high-throughput analysis of biotherapeutics results in the necessity of standardised chromatographic methods, as told by Dr Amy Farell,Dr Sara Carillo, and Dr Jonathan Bones at the National Institute of Bioprocessing Research and Training.
 
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Genomics and DNA
Red Biotechnology

Endonuclease Compliance

New enzyme derivatives are being welcomed across the biopharmaceuticals industry following easier red biotechnology applications, as illustrated by Dr Pablo Domínguez de María on behalf of c-LEcta and Dr Stefan Schoenert at c-LEcta.
 
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RPA Development

Technique Transition

Dr Olaf Piepenburg at TwistDx explores the advantages of recombinase polymerase amplification, which is growing in popularity as an alternative to traditional polymerase chain reactions for testing outside the laboratory.
 
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Tumour Heterogeneity

Alternative Approaches

Dr Ute Boronowsky at Oxford Genetics introduces a new gene editing tool that has been developed to iron out issues often encountered during single-cell analysis.
 
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Biosimilars
Diabetes Biosimilars

Calibrating Expectations

Rafal Kokolus, Dr Doug Niven, and Rohit Sood at Syneos Health claim that diabetes treatments could change following the increasing incorporation of biosimilars as an alternative therapeutic.
 
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ADCs as Therapeutics
ADC Development

Targeted Treatment

Given the rise in usage of antibody-drug conjugates in cancer therapy, addressing the problems they sometimes present is important. Edward Barnes, Dr David Bunka, and Dr Arron Tolley at Aptamer Group demonstrate how aptamers can help alleviate these.


 
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Advancing ADC Technology

The Future of ADCs

Changed approaches and new technologies in the drugs’ development sector has given rise to improved and innovative targeted drugs, as explained byDr Neil Butt at IONTAS.
 
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Targeted Therapies

Engineering Antibodies

Targeted antibodies are always evolving, though the challenges they often come with still remain. Professor Andreas Pahl at Heidelberg Pharma illustrates the ways in which these can be overcome.
 
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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

Protagen Protein Services expands analytical Service Spectrum in Biosimilar Development Support

Heilbronn/Dortmund February 2019: The success or failure of the development of a biopharmaceutical product is also governed by protein stability. Protein stability is considered a critical parameter during manufacturing, production, formulation, long term storage, efficacy, and delivery to patients. To meet our customer demands now and in the future, PPS always invests in new analytical technique and recently added a new Differential Scanning Calorimetry (DSC) device.
More info >>

White Papers

Faster, Better, Cheaper: Lean as a Driving Force Behind Pharmaceutical Companies’ Growth

TBM Consulting Group

The pharmaceutical industry faces countless challenges: patent expirations, weak product development pipelines, downward pricing pressure and an increasingly burdensome regulatory environment. The most important question for companies is now “How can we position ourselves optimally to be successful in the long term?” Some pharmaceutical companies used the economic downturn in 2009 to embrace measures in the fields of cost reduction and efficiency increases, which can be implemented at short notice. The continuous and consistent implementation of sustainable measures that guarantee stability and form the basis for future growth was not necessarily paramount within this.
More info >>

Industry Events

LogiPharma 2019

9-11 April 2019, Montreux Music & Convention Centre

LogiPharma is the world’s leading pharma supply chain event. With over 950+ pharma supply chain leaders exclusively meeting in one place at one time, LogiPharma is THE meeting place to benchmark your business with the best pharma companies and shape the future of your industry.
More info >>

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