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PUBLICATIONS

European Biopharmaceutical Review

ebr
Summer 2014

   
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Editor’s Letter

Deborah O'Neil contemplates the industry's changing climate and reflects on some of this edition's focus features.
 
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STRATEGY AND FINANCE
Dry Shipping

The Physics of Failure


Dan O’Donnell at Fisher BioServices urges companies to pay closer attention to the basic principles of physics when distributing cell-based products. This will allow the focus to stay on the patients and clinical trials, and not on delivery.
 
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BioResearch and Innovation
gmMSC Technology

Mesenchymal Stem Cells 2.0


Technological breakthroughs in the development of next generation mesenchymal stem cells are leading to increasing patient benefits, as well as clinical and commercial success, thinks apceth’s Stefanos Theoharis.
 
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Oral Diseases

Mouth to Mouth


Pierre Attali at BioAlliance Pharma considers why systemic and topical treatments for oral diseases are not always the best option, and recommends the use of mucoadhesive buccal formulations as an alternative.
 
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Iminosugars
 
A Rare Approach


The successful development of iminosugar-based chaperone compounds could be the answer to treating lysosomal storage diseases and many other orphan pathologies. Julie Charollais-Thoenig and Stéphane Demotz at Dorphan SA explain.
 
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Placenta-Derived Therapeutics

Great Expectations


With preeclampsia still a leading killer of pregnant women and a major contributor to foetal morbidity, Pluristem Therapeutics’ Karine Kleinhaus talks about the need to invest research into placenta-derived cell therapies.
 
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Genetic Toxicology

Genotox Support


Andrew Eaton and Matthew Tate at Gentronix muse on how an understanding of genetic toxicology can help chemists to formulate and improve compounds in an effective way.


 
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Discovery Technology
Column Technology

HPLC’s Golden Jubilee


In the first of a two-part series, Ronald Majors from Agilent Technologies looks back at the origins of high-performance liquid chromatography, and reflects on how far this technology has come on the eve of its 50th anniversary.
 
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Novel Therapeutics

Lease of Life


Novozymes Biopharma’s Dermot Pearson suggests how extending the therapeutic half-life of drugs can offer pharma companies new prospects to improve the
profile of their products.
 
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Hypoxia Replication

Prime Conditions


Investigators are embracing new hypoxia workstations which push the boundaries of research capabilities by enabling the capture of real-time dissolved oxygen directly from cell-culture media. Michael Rau at Oxford Optronix reports.
 
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BioDevelopment and Regulatory
Regulatory Update

New Twists for Orphans


Fresh changes at the FDA have had important implications for the orphan drug development process. Timothy Coté at Coté Orphan Consulting guides companies and sponsors through the regulatory minefield.
 
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Cell-BasedPotency Assays

Quality Assurance

When developing a cell-based potency assay intended for product release and quality control, careful considerations need to be taken. Weihong Wang at Eurofins Lancaster Laboratories investigates.


 
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Biosimilars

Making Progress


There has been increasing recognition of the value of biosimilars as a cost-effective answer to the problem of patent expiry and demands for lower priced alternatives. NDA Group’s Dr Gopalan Narayanan provides some thoughts.


 
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Patent Protection

The Secret of Success


Bioproduction processes can offer companies the chance to exploit new subject matter to extend the patent life of a drug. This rise in second-generation copyrights is prompting legal moves, says Paul Calvo at Sterne, Kessler, Goldstein and Fox.
 
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BIOINFORMATICS
Whole Genome Sequencing

Applied Information


Rodrigo Barnes at Aridhia Informatics believes that annotation services are the solution to delivering research data concerning genome sequencing to both clinicians and patients.
 
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INTERVIEW
Industry Interview

Radiation Response

Xstrahl’s Adrian Treverton talks to EBR about the future direction of radiation oncology, and how it can provide more patient-centred healthcare.
 
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INDUSTRY DYNAMICS
Clinical Research Outsourcing

Merging Markets


Vijaya Vulapalli at GBI Research explores how clinical research outsourcing partners are set to cash in on the opportunities presented by pharma’s tough times.
 
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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

Surge of Indian biosimilars market forecast in 2019

16th April 2019: New data from CPhI shows that, despite ongoing reputational challenges, India’s biologics market is set for robust growth in 2019 driven by biosimilars production. The India specific findings from CPhI’s bio league tables predict strong ‘bio growth potential’ in India throughout 2019 in the build-up to the 13th edition of CPhI India 2019, which will take place at the India Expo Centre in Delhi NCR.
More info >>

White Papers

Detecting Integrity Breaches in a range of Pharmaceutical Blister Package Types using Sepha VisionScan

Sepha Limited

Demonstrating the integrity of pharmaceutical blister packs is critically important, as any defects can affect the shelf life and efficacy of the contents. Compared to bulk packaging, blister packs offer improved product integrity, tamper evidence and reduce the likelihood of misuse. Packs can be composed of either a thermoformed polymer or cold formed aluminium tray, with a number of individual pockets to hold the product. After the tablets or capsules are placed in the pockets, the packs are heat sealed with a paper or foil laminate sheet. These various stages can be completed separately or integrated into a single form, fill and seal process. There is a risk of microbial containment or degradation of the contents if any defects are present in the packaging. Such defects can take the form of rips or pinholes in the tray, or lid materials, faulty seals and channel leaks between pockets.
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Industry Events

World Pharma Week 2019

17-20 June 2019, Seaport World Trade Center, Boston

World Pharma Week will bring together a unique and international mix of large and medium pharmaceutical and biotech companies, CROs, leading universities and clinical research institutions, emerging companies and tool providers—making it a perfect meeting-place to share experience, foster collaborations across industry and academia, and evaluate emerging technologies.
More info >>

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