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Dr Kiren Baines, Analytics Lead at eXmoor Pharma, details some of the critical steps when validating an assay or analytical method, including key considerations for developing an experimental plan aligned with ICH guidelines.
Killian O’Driscoll, Director of Projects at the National Institute for Bioprocessing Research and Training (NIBRT), highlights the plight of a future skills shortage in the global biopharma industry as state-of-the-art therapy production evolves at a rapid pace.
At first glance pharmaceutical packaging such as a tablet carton or medicine bottle appears to be the simplest of things. However, the humble package serves multiple and varied needs and increasingly includes a surprising range of technology. Reddie & Grose LLP’s Zack Mummery, Dale Carter and Andy Attfield explain more.
We are experiencing a time of polarity in our healthcare systems with breakthrough treatment options developed, but access prohibited. Here, Catherine Owen, SVP of Major Markets at Bristol Myers Squibb, explains why, despite continued COVID-19 pressures, the time is ripe to rectify this situation.
Discover how GSK and Aragen Biosciences streamlined their processes using various techniques that produced multiple benefits, including increased throughput, improved quality control and reliable automation.
Here, industry experts from bioMérieux Industry, Charles River, Shimadzu, TA Instruments, Thermo Fisher Scientific and WITec share their research, guidance and pharmaceutical knowledge.
Articles in this in-depth focus explore how to promote patient access to breakthrough treatments across Europe and discuss some of the latest and greatest innovations in packaging.
This in-depth focus explores recent developments in pharmaceutical stress testing and why collaboration is key in the development of cancer therapeutics.
In this in-depth focus, experts discuss how a future skills shortage may impact the biopharma industry and the key considerations when validating assays and analytical methods for ATMPs.
Here, Dave Elder discusses some encouraging progress in the development of novel excipients, highlighting what this means for the industry.
In late October, we learned that an exciting and ambitious new entity – the Bespoke Gene Therapy Consortium (BGTC) – had come into being in the US, designed to encourage the delivery of more gene therapies for rare diseases. The consortium is an interesting construct, headed and funded by the…
In this in-depth focus, discover how Raman spectroscopy is used by Bristol-Myers Squibb to identify counterfeit pharmaceuticals and the role of artificial intelligence in rapid microbiological method development.
In this article, Robert Newman and Tom Fletcher explore how the bioprocessing industry has changed in the last 50 years and where the future may lead…
The valsartan nitrosamine contamination issue was probably the most significant quality issue to hit the pharmaceutical industry in a decade. Here, Dave Elder outlines how agencies and manufacturers are dealing with the problem and indicates the knowledge gaps that might be concealing future complications.
This journal features articles discussing what knowledge could help the industry to prevent the next nitrosamine-like contamination event, the key steps when validating analytical techniques for cell and gene therapies and how artificial intelligence is shaping microbiology. Also in this issue, using Raman spectroscopy and hyperspectral imaging to detect counterfeit…
