European Biopharmaceutical Review |
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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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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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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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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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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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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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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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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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