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European Biopharmaceutical Review

ebr
Autumn 2018

   
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Editor’s Letter

EBR's Editor, Dr Deborah O'Neil, details all the innovations touched upon in this issue and how the majority can enhance cancer treatment.
 
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peptides and proteins
Label-Free Biosensing

Protein Progression

Following a significant increase in quality, peptide and protein microarrays now have the potential to offer brand new opportunities in pharmaceutical and proteomics R&D, claims Güenther Proll at Biametrics.
 
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Process-Specific Versus Generic Host Cell Protein Impurity Assays

Biologics Process Analysis

Given the rise in therapeutic antibody production, it has become more important than ever to address issues associated with host cell proteins, as detailed by Ken Hoffman, Eric Bishop, Dr Alla Zilberman, and Dr Jared Isaac at Cygnus Technologies.
 
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Generating High-Quality Protein Reagents from Eukaryotic Cells

Cell Culture Considerations

Both Escherichia coli and eukaryotic systems have their pros and cons, yet the former is selected more often due to speed and cost implications. Dr Mark Abbott at Peak Proteins discusses the factors to be considered.


 
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Improving Pharmacokinetic Assays in a Regulatory Bioanalysis Setting

Applying Affimers

Dr Amanda Nicholl at Avacta Life Sciences expresses the fundamentality of pharmacokinetic assay results in the phases of drug development and how to increase the effectiveness and efficacy of antibody drug development.
 
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Peptides in Plasma

Determining Peptides

Determination in plasma can be particularly complicated, especially when dealing with peptides, but Professor Hermann Mascher at pharm-analyt believes it is still a route worth taking.
 
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Formulation and Quality Control
Purifying Oligonucleotides

Produce Potential

Dr Cecilia Unoson and Dr Lars Haneskog at Bio-Works Technologies delve into whether the necessary yield and purity of oligonucleotides can be attained through anion exchange chromatography.
 
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Innovations in Oncology
Advanced Therapies

Rising to the Challenge

Dr Fiona Thistlethwaite at The Christie Hospital and Dr Ian Thomas at Aptus Clinical explore the challenges of bringing advanced therapy medicinal products to market and the considerations that must be made.
 
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Tissue-Agnostic Approvals

A New Oncology Era

New advances in tumourigenesis have laid the foundations for a molecular marker that assists in defining and treating cancers, explains Dr Terese Johansson at NDA Group.
 
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Cancer Therapy Innovations

Oncological Advances

Dr Kathryn D Bungartz at N-of-One provides an overview of how advanced imaging techniques and improved preventative measures have transformed the world of cancer innovation.
 
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In Vitro Bioassays

Candidate Selection

The cancer immunotherapies field has made notable progress in its clinical application, and combination therapies may be a viable force to drive these advancements further, suggest Thibault Janss and Sofie Pattijn at ImmunXperts.
 
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Diafiltration of Antibody-Drug Conjugates

Novel TFF Capsule Evaluation

The teams at Sanofi and Merck Group demonstrate the advantages of antibody-drug conjugates as cancer chemotherapeutics.
 
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Bioelectronics
Electroceutical Therapy for Chronic Pain

Effective Electroceuticals

Dr Sree Koneru at BioElectronic Corporation and Dr Kenneth McLeod at the State University of New York in Binghamton, outline the benefits of electroceutical treatments for many neurological disorders and compare this to the widely recognised central sensitisation.
 
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Benefits of Bioelectronic Medicine

Theory to Game Changer

As the use of bioelectronics is on the rise following the adoption of electric devices as main treatment options, Pascaline Vancraeyenest at Healtech identifies how the reliance on drugs is potentially becoming limited.
 
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The Future of Bioelectronic Medicine

Targeted Technology

Dr Deepak B Thimiri Govinda Raj, Prasanna Subramaniam, Dr Sri Saran Venkatachalam, and Dr Dinh-Toi Chu at Envirotransgene Biosolutions examine why bioelectronic medicine is regarded as a disruptive technology in healthcare.
 
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biopharmaceutical technology
In Brief

GOAL!

Following this year's approval of the first RNA interference-based human therapy, EBR's Industry Advisor, Emile Bellott, takes a look at its new role as a game-changer within the biopharma industry.
 
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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

Recro Gainesville Adds New Facility, Broadens Capabilities With High-Potent Processing on Deck

Gainesville, Ga., Nov. 5, 2018 (Business Wire) – Recro Gainesville has added a 24,000-square-foot facility, which includes high-potent material processing space, near its existing 97,000-square-foot contract pharmaceutical development and manufacturing plant. The company is a wholly owned subsidiary of Recro Pharma, Inc., and a leading provider of solid oral dose development and manufacturing services for the pharmaceutical industry.
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White Papers

Medpace Reference Laboratories establishes state of the art Flow Cytometry techniques for flexible approaches to clinical trials across multiple therapeutic areas.

Medpace

Cytometry is the process of measuring the properties of individual cells. These properties may include gene or protein expression, chemical properties, deoxyribonucleic acid (DNA) content, and various cellular functions. The earliest methods of cytometry relied upon light microscopy for the classification and observation of cells and cellular components. Microscopy permitted direct visual observation of cells for the first time, leading to the classification of cells by morphology and insight into cellular functions. However, the time required for microscopic analysis constrains the number of samples or number of cells in each sample that can be examined. Therefore, the utility of microscopy for analysis of rare cells or in situations where sample throughput is a priority is limited. Flow cytometry was developed largely to improve upon these limitations.
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Industry Events

Pharma and Device Packaging and Labelling West Coast 2018

27-28 November 2018, Burlingame, CA

The second edition of the Pharma and Device Packaging and Labeling West Coast was a thought-provoking two days of engaging presentations, discussion and networking.
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