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| home > ebr > Summer 2017 |
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 PUBLICATIONS |
European Biopharmaceutical Review |
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Editor's Letter
Editor’s Letter
Offering an overview of this issue, EBR Editor Dr Deborah O’Neil covers the problems facing creators of rare disease treatments and the ongoing debate surrounding genetic engineering.
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Therapies for Blood Cells
Upcycling Genomics
Dr Franziska C Ruf at SIRION Biotech suggests that advances in the gene therapy sector, using hematopoietic and stem cells, will lead to a cure to heritable diseases, such as asthma, arthritis and cancer.
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Oligonucleotides and Separation
Complex Characters
Characterising oligonucleotides is a process fraught with analytical challenges, but it is showing positive results in clinical trials and continues to gain traction within biopharma organisations, says Jon S Kauffman at Eurofins Lancaster Laboratories. |
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Achievements in Protein Manufacture
What about Pichia?
Advances that remedy current recombinant protein expression problems are exposing one yeast as a more efficient system for manufacturing therapeutics, reveal Thomas Purkarthofer, Iskandar Dib and Evelyn Trummer-Gödl at VTU Technology.
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Pharmaceutical Stability
Protein Productivity
Lisa Newey-Keane at Malvern Instruments proposes that analytical tools for evaluating stability, such as the latest DSC instruments, could help scientists gather important information with greater efficiency and accelerate liquid formulation.
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Orphan Disease Legislation
Acting Up
The Orphan Drug Act might require updating, stress Matthew Weinberg and Emily Krulewitz at The Weinberg Group, as its efficacy continues to be debated and a lack of clear-cut distinctions are allowing some to cheat the system.
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Q&A: Rare Disease Dilemma
Sustainable Solutions
In this interview, Hege Hellström at Sobi EMENAR and Neil Dugdale at Sobi UK and RoI explain why a long-term approach to the treatment of rare diseases is key and discuss why the company advocates collaboration with stakeholders.
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Gene-Editing
Cut and Paste
The science fiction-like concept of gene-editing faces a barrage of ethical concern from parties across the industry as well as wider fields, but Jimmy Muchechetere at Investec Wealth & Investment believes it is an opportunity that could transform pharma.
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Focus on Pharmacovigilance
Strategic Advantage
ProductLife Group’s Cheryl Key determines that maintaining investment in pharmacovigilance processes has become more significant following the escalation of globalisation and resulting heightened business demands.
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In Brief
In Your Genes
EBR’s Industry Advisor Emile Bellott explores the recent FDA approval of direct-to-consumer genetic testing for a variety of diseases.
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Biosimilars Development
Revolution or Evolution?
The pharma industry does not exist in a vacuum and, as such, the economic and political climate have a substantial impact on the market and manufacturers of biosimilars, according to Guillaume Plane at Merck.
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Mature Products
Organisation Optimisation
David Balderson at Sciformix Corporation acknowledges the opportunities outsourcing offers, as he points out that effectively managing an already established portfolio of products is just as critical as the development of new ones.
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Comparability Analysis
Dissecting Structures
BioPharmaSpec's Dr MI Millichip and Dr AJ Reason argue that biosimilarity assessment guidelines are not sufficiently precise regarding determination of higher order structure. It is necessary for these tests to go hand-in-hand with primary structure characterisation.
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Biologic Classification
QbD in Action
Although it can introduce further associated difficulties, Simon Cubbon at Thermo Fisher Scientific advocates the use of high-resolution mass spectrometry within QC and lot release for routine biopharma characterisation.
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Personalised Therapeutics
Hidden Treasures
New small molecule biomarkers, which can be discovered through mass spectrometry, could enable a clearer understanding of the precise impacts of medicine and allow drugs to more effectively treat diseases, according to Professor Hermann Mascher at pharm-analyt Labor.
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Bioanalytical Technology
Teething Problems
Richard Hucker, Ian James, Scott Vincent and Carl Watson at A4P Consulting remind us that key decisions need to be made from science, operational and business perspectives throughout the drug development process and the transition to clinical activities.
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News and Press Releases |
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PCI Clinical Services Announces New Facility Dedicated to Clinical Trial Returns
Philadelphia, USA – October 15, 2018. Leading international pharmaceutical outsourcing services provider PCI Clinical Services (PCI) has announced the completion of a dedicated Returns Management facility at its Clinical Services Center of Excellence at Bridgend, UK. PCI provides a full service Returns Management service for clients, providing visibility and accountability in returning investigational drug product from investigational sites at the conclusion of a clinical study. Returning and reconciling Investigational Medicinal Product (IMP) on completion of a study is a critical part of a Clinical trial and can require complex reverse logistics. Trial outcomes can be impacted if Returns are not processed efficiently and precisely.
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White Papers |
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Life Cycle of an Analytical Method - a Case Study on the Monocyte Activation Test
Wickham Laboratories Limited
Pyrogens, a heterogeneous group of fever inducing contaminants, are comprised of microbial and non-microbial compounds; e.g. endotoxin (lipopolysaccharide, LPS) produced by Gram-negative bacteria, lipoteichoic acid (LTA) from Gram-positive bacteria, bacterial DNA (CpG-motive), endogenous pyrogens, virus and fungi particles or even fragments of packaging materials, plastic and dust. Contaminat ion wi th pyrogens in pharmaceutical products, biotherapeutics and on medical devices can lead to life threatening fever reactions. To ensure consumer safety, pyrogen testing is mandatory for parenteral products and medical devices.
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Industry Events |
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Pharma Packaging and Labelling East Coast 2019
20-21 February 2019, Phildaelphia, USA
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