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European Biopharmaceutical Review

Editorís Letter

We have watched with horror as the latest Ebola outbreak rips through West Africa. Just as terrifying, albeit in a very different way, are the stocks of smallpox, anthrax and H1N1 influenza which were recently discovered in a freezer at a National Institute of Health laboratory. These are timely, yet dramatically distinct reminders that in no way are we ahead in the anti-infectives and vaccine race. The discovery of such pathogens in a US government research facility is a stark reminder to anyone working with biological agents of this class to ensure best practice in laboratory management and inventory.

Discovery collaborations can accelerate innovation in therapeutic development, and two models for this are discussed in our current issue. Open innovation as a driver for progress in biopharma R&D is contemplated by Simon MacKenzie and Sylviane Boucharens of BioAscent Discovery Ltd (page 62), while Quintilesí Peter Wagner and Christoph Schnorr discuss broader collaborative structures between industry, patients, payers and other stakeholders (page 58).

Cell culture is a key tool of the R&D trade, both in drug discovery and biomanufacturing. In this edition of EBR, a range of articles address major considerations for best practice in mammalian cellbased systems. BioCisions' Rolf Ehrhardt and Maria Thompson consider the importance of temperature Editorís letter standardisation in cell culture process control (page 40), and the impact of culture media and experimental design on mammalian cell-based production processes is covered by Francesc GÚdia from the Universitat AutÚnoma de Barcelona (page 34).

Manipulation of cell lines by transient transfection in the drug discovery and manufacturing spheres is a topic broached by Karen Donato, Krista Steger and Meg Duskin at MaxCyte, Inc (page 24), while in our industry interview, Alison Porter from FUJIFILM Diosynth Biotechnologies shares her thoughts on current stateof- the-art processes and important considerations in mammalian cell lines as microfactories for biomanufacturing (page 28).

Your October edition of EBR also features some highly informative articles on imaging: molecular techniques in drug development (page 46) and kinetic modelling in oncology (page 48); separation and analytical technologies (page 66); SDS-PAGE and liquid chromatographymass spectrometry (page 30); and nanotechnology (page 52).

Back to the topic of anti-infectives and, in particular, the positives of the Longitude Prize. The fact that a solution for better detection and diagnosis of bacterial infections has been selected demonstrates the level of public awareness of the anti-infective pipeline crisis we are facing, as well as the need for new and better ways to manage and treat communicable disease. You might also say that the Longitude Prize is a call-to-arms for a personalised medicine approach to antibacterials Ė an issue also covered, from the regulatory perspective, by EBRís own Emma Naks (page 14) and CMSís Shuna Mason (page 18) Ė and for using more tailored, evidencebased, patient-specific antibiotic therapies. It is great profile-raising for this cause and, as someone at the front-line of industry efforts, it is very welcome.

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