List view / Grid view
Elizabeth Anne Wright, Head of the EU regulatory life sciences team at law firm Cooley, and associates Jessica Koffel and Edward Turtle look ahead at EU regulatory milestones for the life sciences sector in 2023. Five key areas of potential change include: clinical trials, medical devices, pharmaceutical legislation, class actions…
With manufacturing of essential medicines in Europe at risk, Teva’s Phillippe Drechsle looks at the action needed to stop further offshoring to Asia.
This ebook takes an in-depth look at advanced analytical methods for extractables and leachables analysis in the pharma industry.
Here, microbiology experts Tim Sandle, Tony Cundell and AstraZeneca’s Miriam Guest reflect on key developments in pharmaceutical microbiology during 2022.
The preparation of buffer solutions is a crucial component in the downstream manufacturing process for biomolecules; however, it is also one of the most resource-heavy and intensive steps. Solving these downstream issues with new approaches is critical to achieving efficiency and commercial gains within the upstream process. Here, Andrea Johnston…
Here, Sanofi’s Arnaud Robert and Brendan O’Callaghan explore how advances in digital technology, partnerships and new ways of working are supporting manufacture and delivery of medicines for patients across the globe.
It is possible to manufacture monoclonal antibodies using traditional methods, but the challenges inherent in bispecific antibodies such as low titer, mismatched chains, unwanted fragments and higher aggregation levels require a heightened analytical focus on clonal cell selection. Here, Stuart Jamieson and Alice Harrison at Lonza discuss high-throughput analytical strategies…
Carsten Rudolph and Christian Plank of Ethris, an mRNA therapeutics and vaccine‑focused German biotechnology company, discuss the current state of the art in the field, including delivery systems and administration of mRNA drug candidates to prevent or treat a plethora of diseases.
Raman mapping is a powerful tool that can be used to reveal details about the size and spatial arrangement of components throughout a tablet matrix. Here, Andrew Ewing, Don Clark and Fiona Clarke from the Materials Characterisation Team at Pfizer present a 3D imaging approach using Raman mapping to investigate…
In this article, Aman Khera and Dr Christine Moore of Worldwide Clinical Trials share how regulatory agencies are supporting psychedelic research through expedited pathways and outline some of the key considerations for clinical trials sponsors.
Articles on high-throughput analytics for optimising bsAb clonal cell selection and a technology to overcome buffer preparation bottlenecks.
Articles explore the potential of tryptamines in treatment-resistant depression and drug delivery options for mRNA therapeutics.
Here, Snehit Satish Mhatre and Michael Timm of Eurofins discuss considerations and recommendations for the testing of live biotherapeutic products.
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.
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…
