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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 byJennifer 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

rfxcel Covers the Cost of EMVO Onboarding Fees

May 23, 2018 - San Ramon, CA – rfxcel Corporation, a technically certified Gateway Provider for the European Medicines Verification Organisation (EMVO) announced today that it will pay the cost of statutory fees payable to EMVO* for all manufacturers (Marketing Authorisation Holders, MAHs) which select rfxcel as their Gateway Provider before June 15th 2018.
More info >>

White Papers

Delivering Fit For Purpose Biomanufacturing CHO Cell Lines

Fujifilm Diosynth Biotechnologies

The challenge during mammalian cell line development is to identify and isolate stable, high expressing cell lines producing product with the appropriate critical product quality attributes rapidly, reproducibly and with relative ease. Obtaining a host cell line that inherently exhibits desirable biomanufacturing attributes can therefore have a significantly positive effect on the identification of recombinant cell lines with desired traits during cell line development screens. In this study, we demonstrate that it is possible to exploit intrinsic heterogeneity within host cell populations and identify host cell lines which are more “fit for purpose”.
More info >>

Industry Events

SMi’s 5th Molecular Diagnostics Conference

9-11 July 2018, Holiday Inn Kensington Forum, London, UK

SMi is proud to announce their 5th Molecular Diagnostics conference. The event will take place in central London on Monday 9th and Tuesday 10th July 2018, along with two half-day post-conference workshops taking place on Wednesday 11th July 2018
More info >>

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