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European Biopharmaceutical Review

ebr
Spring 2017

   
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Editor’s Letter

Dr Deborah O’Neil, Editor of EBR, highlights the connections and debates that interlink the articles by our contributors this issue, with a particular focus on the protein problem and the need for tighter regulation across fields such as biomarkers and personalised medicine.
 
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Drug Discovery
Biological Complexity & Drug Discovery

A Complex System


When considering the cell as a complex system it is possible to uncover new opportunities in drug discovery, says Jonny Wray at e-Therapeutics – and their applications are wide-ranging and certainly beneficial.
 
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Identifying the Need for New Drugs

Opening Doors


Benoît Laleu, Jaya Banerji and Paul A Willis at Medicines for Malaria Venture discuss the Malaria and Pathogen Boxes, which emphasise the importance and benefits of collaboration and open source approaches in drug discovery.
 
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BUSINESS STRATEGY
In Brief

Just Value


Emile Bellott, EBR’s Industry Advisor, investigates how to successfully create a supply-side business model taking into account value in negotiating with manufacturers on drug prices.
 
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CDMO Developments

Seize the Market


Rentschler Biotechnologie’s Dr Stefan R Schmidt and Dr Birgit Schwab investigate how mid-size contract development and manufacturing organisations can take advantage of the biopharmaceutical market. Updating their facilities and researching personalised medicines, they argue, could be the answer.
 
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RESEARCH AND DEVELOPMENT
Spotlight

Managing E&L Unknown Compounds


With unknown compound characterisation representing a challenging aspect of analytical chemistry, Eurofins BioPharma Product Testing investigates extractables and leachables as well as the importance of knowing your compounds.
 
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CELL-BASED RESEARCH
Cells and Serums

Culture Clash


Jessie HT Ni at Irvine Scientific explores the latest developments in the world of serums. With their benefits and risks well known, we are beginning to further understand their effects on phenotypes and, as a result, our knowledge of cell biology is expanding.
 
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Q&A: Genetic Modification

Express Yourself


We learn about the possibilities of cell engineering, genetic modification and protein production in this Q&A feature with the team at Oxford Genetics, who say that it could be possible to cure inherited diseases with new technology.
 
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THERAPEUTIC DEVELOPMENT
Protein Identification

Becoming Better Informed


Christian Loch at AVMBioMed suggests that proteomics may be the best tool for characterising investigational molecules and identifying useful biomarkers. However, this needs to be done more reproducibly and should account for post-translational modification.
 
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Biomarkers and Personalised Medicine

Essential Tools


Dr Mélanie Bodnar-Wachtel and Dr Tanja Schubert at Bioclinica Lab reveal how biomarkers are being used in the treatment of Alzheimer’s disease and cancer. As they become essential, they are revolutionising the manufacture of advanced therapies and allowing for new and innovative practices and partnership.
 
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Therapeutic Transportation

Stay Cool


When transporting manufactured drugs, there are many factors that have the potential to damage product integrity. John Fink and Katheryn Shea at Brooks Life Science Systems explore best practices to avoid this with regards to cryopreservation.
 
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Protein Production

Balancing Act


Cytovance’s April Stanley explores different approaches for successful therapeutic protein production. The most effective ones, she argues, involve both integration and partnership.
 
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Patient Stratification

Personalised Immuno-Oncology


As global cancer diagnoses are set to surge, the implementation of biomarkers like autoantibodies could be a saving grace for the development of effective immunotherapies in the field of oncology, argue Dr Peter Schulz-Knappe and Dr Georg Lautscham at Protagen.
 
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Q&A: Biomarkers in Oncology

Pinpointing the Problem


ICON LaboratoriesDr Mario L Rocci Jr shares his insights on the use of biomarkers in oncology with particular focus on PD-L1 and tumour-infiltrating lymphocytes.
 
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Influenza Viruses

Going Viral


Human challenge trials could lead the way in real world validation of medication efficacy, believes Adrian Wildfire at SGS Life Sciences. He states that various strains of the influenza virus are acceptable candidates for such studies, and explains some of the reasons why they are so effective.
 
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Peptides and Proteomics

Perfecting Progress


Although proteomics lacks sufficient global legislative procedures, Kim Plasman, Kris Gevaert, Francis Impens and Tony Montoye put forward several methods for improving the quality of workflows through accurate peptide quantification.
 
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Published quarterly in
January, April,
July, and October

News and Press Releases

Joining forces against SARS-CoV-2

Laupheim, Germany and Milford, MA, USA, October 08, 2020 - Rentschler Biopharma SE, a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals, today announced an agreement to serve as CDMO partner for BioNTech. As an initial project, Rentschler Biopharma will be responsible for key aspects of cGMP (current good manufacturing practice) drug substance manufacturing of BNT162b2, the mRNA-based vaccine against SARS-CoV-2 that is being developed by Pfizer and BioNTech, and is currently in a global Phase 3 clinical trial.
More info >>

White Papers

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With the incremental demand for proactive safety surveillance throughout the conduct of clinical trials, the role of Medical Management is at the fore in ensuring the safety and wellbeing of the participants. The complex responsibilities of a Medical Monitor (MM) starts from the design and development phase, through to study close out. Understanding the principle behind the protocol and the prospective medical solution the study would deliver forms the bloodline for the MM role. Often, the MM is the face of contact for both the site personnel and the study team members with regard to medical, safety and scientific issues within the project. When it comes to medical guidance, the communication channel used to deliver solutions contributes to a large extent in effectively managing decisive situations. Our previous study on acquiring medical guidance from an operations team perspective revealed that e-mails were the most used communication method (see the article, 'Talking Points', in ICT November 2014). In our efforts to further strengthen the mode of medical guidance delivery, we designed a survey to study the existing trend and constraints in this communication chain management, as outlined here.
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