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PUBLICATIONS

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

PCI and CSP Technologies, Inc. Announce Strategic Collaboration for Breakthrough Activ-BlisterTM Solutions

Philadelphia, PA & Auburn, AL – September 17, 2018 PCI Pharma Services (PCI), a full-service provider of specialist outsourced drug manufacturing, clinical trial services, and commercial packaging to the global healthcare industry, is pleased to announce its exclusive collaboration agreement with CSP Technologies, Inc. for U.S. clinical trials and stability testing utilizing Activ-BlisterTM packaging solutions, which help protect and promote speed-to-market for pharmaceutical and medical device products with heightened susceptibility to moisture and gases, especially oxygen.
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White Papers

Points to Consider When Developing a TMF (Trial Master File) Strategy

Phlexglobal Ltd

Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation. The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems. As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
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Industry Events

PDA Universe of Pre-Filled Syringes and Injection Devices

8 October - 9 November 2018, Loews Royal Pacific, Orlando, FL

At the 2018 PDA Universe of Pre-filled Syringes and Injection Devices,industry and regulatory experts will share experiences, new developments, regulatory considerations, challenges, and industry trends and best practices. This is a must-attend event for all industry professionals involved in the development, manufacturing, testing, or marketing of pre-filled syringes and injection devices.
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