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European Biopharmaceutical Review

Editors Letter

The age of the biosimilar has most definitely dawned. These ‘generic biologics’ are now licensed on both sides of the Atlantic. Approval scores currently stand at Europe: 20, US: 1, but this will undoubtedly start to even out now that the pathway to approval has been set out globally. The Eurofins team and ProductLife Group’s Barbara Testa take us down the road to biosimilar development and the process requirements to achieving a viable therapeutic in this class.

The KBI Biopharma team explain how their high-throughput process development systems can refine and accelerate production and optimisation processes on smaller scales and at less cost without compromising on data quality. Cell lysis in biomanufacturing and the optimisation of this as a critical step in the process are highlighted by Dr Matthew Lougher from Constant Systems, who explains that it is not merely a case of “one number fits all” with regards to setting pressure parameters.

We are also moving quickly towards a digital era. Veeva Systems’ John Chinnici touches on one aspect of biopharma process management in this edition, together with efficiencies and streamlining through a single system digital content management. Staying digital, the Arthur D. Little team look to an eHealth future and its impact on the pharma industry and healthcare in general.

The possibility of diagnosing – and even early screening for – certain cancers through ‘liquid biopsies’ potentially carrying circulating cancer cells has to be an exciting non-invasive alternative to traditional solid tissue biopsies whenever possible. In the first part of his article, Paul Elvin from Aptus Clinical discusses the technical aspects and benefits of this approach and hints at its potential application in a wider range of oncology treatments than it is currently employed in. Metals such as iron, zinc and copper – flagged as potential biomarkers of more aggressive tumours in the case of breast cancer, for example – could perhaps, one day, also be detected in circulating cancer cells from liquid biopsies with the modification of Diamond Light Source’s techniques.

Max Ryadnov from the National Physical Laboratory introduces us to the concept of engineered virus-like nanocapsule delivery of therapeutic RNA, potentially for a range of single gene hereditary conditions. Quantifying and controlling the amount of RNA delivered by the virus-like nanoparticles will be essential for the successful implementation of this approach as a therapeutic intervention. The microscopy applications employing short pulse, ultra-fast lasers and next-generation fluorophores introduced by Andrew Wells from Laser Quantum, would certainly be one means by which to assess cellular uptake of these novel RNA structures.

In this edition’s industry interview, the key role of conferences in facilitating advances in diseases such as idiopathic pulmonary fibrosis (IPF) is discussed with Dr Marilyn Glassberg. Dr Glassberg explains how the American Thoracic Society’s annual meeting is a vehicle for gathering data, clinical experience, the pharma industry and thought leaders all under one roof, and has helped with developments in IPF and other such conditions.

Finally, our spotlight on dementia coincides with a keynote address at the biotechnology industry’s major global conference, BIO, by no less than Will Smith and Bennet Omalu – a Hollywood actor and forensic neuropathology double-act, linked by a biopic of the discovery of sports trauma-related brain disease – to highlight the criticality of further neurological research for a better understanding of Alzheimer’s and other forms of dementia. Aridhia’s Rodrigo Barnes explains how this can be achieved through new, non-competitive, collaborative approaches – including the European Prevention of Alzheimer’s Dementia project. These initiatives will hopefully accelerate the journey to better treatments, or even cures, for the tens of millions worldwide who will otherwise be afflicted by a form of dementia.

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Dr Deborah O'Neil
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