Whole genome sequencing and analysis of live biotherapeutic products
Here, Snehit Satish Mhatre and Michael Timm of Eurofins discuss considerations and recommendations for the testing of live biotherapeutic products.
List view / Grid view
Articles
Patient-centred pharmaceutical packaging: are we there yet?
Despite tremendous innovation in the realm of pharmaceutical therapeutics, the packaging of medicines has been staid. In this article, Giana Carli Lorenzini from the Technical University of Denmark investigates the potential of patient-centred pharmaceutical packaging.
Building CO2-neutral, defossilised supply chains for chemicals
Manufacturers of (bio)pharmaceuticals, medical devices and in vitro diagnostics have the opportunity to lead the way in the defossilisation of organic chemicals. Here Martin Held from the Institute of Biotechnology of the Swiss Federal Institute of Technology and Roche’s Stefan Koenig, Martin Olbrich and Jan Backmann propose how to reduce…
Clinical innovation: using digital solutions to deliver the next wave of medicines
Rapid progress in digital health technologies is enriching clinical trial design, improving clinical trial recruitment strategies and harnessing the power of clinical trial data to improve outcomes for patients and guide future research. Here, Natalie Fishburn, Cristina Duran and Serban Ghiorghiu, from R&D at AstraZeneca, discuss the evolving nature of clinical innovation…
Converging knowledge and technology to transform neuromuscular disease treatment
With the emergence of innovative therapeutic technologies and progress in the genetic understanding of diseases, Biogen’s Toby Ferguson explains why it is a promising time for the development of therapies for neuromuscular conditions such as amyotrophic lateral sclerosis (ALS).
Interchangeability of biosimilars in the EU – the industry impact
In a reversal of approach, EU medicines regulators have for the first time published a statement supporting the interchangeability of biosimilar medicines in the EU. Here, Marie Manley and Chris Boyle from Sidley Austin LLP explore what this could mean for biopharma companies.
The potential of tryptamines in treatment-resistant depression
There is growing interest in the use of psychedelic-assisted therapy for treatment of mental health conditions. Here, Guy Goodwin, Chief Medical Officer of COMPASS Pathways, explores the potential of tryptamines to treat depression, sharing results from a recent clinical trial.
The lingering menace of diethylene glycol / ethylene glycol adulteration
Although it was first identified in the 1930s, diethylene and ethylene glycol contamination remains an issue today, as Dave Elder explains.
European Pharmaceutical Review Issue 6 2022
This issue includes articles on Raman mapping of pharmaceutical tablets, delivery options for mRNA therapeutics, the use of high-throughput analytics for clonal cell selection and much more...
The promise of telomerase inhibitors for treating blood cancer
Geron’s CEO Chip Scarlett discusses the company’s leading telomerase inhibitor in this exclusive interview ahead of the 2022 American Society of Hematology Annual Meeting.
France’s ATU reform: early access remains possible, but not all diseases are equal
When France's ATU reform was implemented, some viewed it as restrictive. Here, Cécile Matthews and Charlotte Capdevila explore the reform’s impact on early access to oncology drugs and products for rare diseases.
Can holograms help in the frontline fight against pharmaceutical counterfeiting?
With Europol advising that counterfeit pharmaceuticals continue to pose ‘…a substantial threat to the EU and affect most, if not all, member states’, Dr Paul Dunn, chair of the International Hologram Manufacturers Association, looks at developments in authentication holography.
Innovation in pharma manufacturing quality systems
Over the last 10 years, there has been an important change of focus in pharma towards biotech products and personalised therapies. These important new treatments are now emerging into manufacturing, with implications for the way that quality is monitored, managed and assured. Dr Eduard Cayón sets out some practical advice.
GAMP 5 update: computerized system expectations for pharma manufacturers
The International Society of Pharmaceutical Engineering’s GAMP® 5 guidelines steer validation practices for pharma companies to meet computerized system expectations. Members of the GAMP steering committees, Lorrie Schuessler, Charlie Wakeham and Stephen Ferrell, share the some of the key changes in the second edition update and how these should be…
Heart failure: clinical trials update 2022
EPR rounds up results from several key clinical trials on therapies for hypertension and heart failure presented at the American Heart Association’s Scientific Sessions 2022.
