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.
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Here, Dave Elder discusses some encouraging progress in the development of novel excipients, highlighting what this means for the industry.
Many hands make light work: why the new Bespoke Gene Therapy Consortium is a godsend for ambitious biopharma teams
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…
The global generics drug market is anticipated to grow to $574.63 billion by 2030, owing to the increasing application of robotic process automation, branded medicine patent expiries and the rising prevalence of chronic diseases.
Artificial intelligence (AI)-based image analysis tools have the potential to completely revolutionise cancer diagnostics, saving time and money by reducing the need for lab testing and expanding global access to cancer diagnostic services. Here, Pahini Pandya, CEO Panakeia Technologies, discusses such technologies and their potential benefits.
Long before the advent of Coronavirus, next-generation therapies were making headlines, but the successful development of COVID-19 vaccines, including mRNA vaccines, has now shone a spotlight on next-generation therapies. This offers a boost to the long-term growth projections for the advanced therapy medicinal products (ATMPs) sector. But although ATMPs hold…
Creating new biologic drugs from early research is a complex process, but certain development methodologies and practices are proving to reach clinical and commercial goals faster. In this article, Seahee Kim from Samsung Biologics provides insight into how contract development and manufacturing organisations (CDMOs) are applying new and effective methodologies…
In this article, Dr Michael Koeris, Associate Professor, Bioprocessing at Keck Graduate Institute, and Carolina Moraes de Souza, Keck MEng graduate, now Process Development Senior Associate at Amgen, discuss the key formulation considerations for bacteriophages, a potential solution to antimicrobial resistance, and why process development should be an early consideration.
Here, Daniel Ghinn of CREATION.co discusses the growing role social media analysis is playing in helping to provide pharmaceutical companies and health regulators with real-world evidence on drug safety.
Kris Sterkens, Company Group Chairman of Janssen EMEA and Managing Director of Janssen Pharmaceutica considers how alterations made to COVID-19 vaccine development procedures could benefit future drug development pipelines.
Patricia Grace, Senior Director, Eurofins Professional Scientific Services (PSS) Europe, shares reasons for the success of the model within the bio/pharma industry.