Key developments in pharmaceutical manufacturing – September 2023
This article outlines the recent progress of several major new manufacturing facilities that will be central in supporting the production of innovative therapies in Europe.
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This article outlines the recent progress of several major new manufacturing facilities that will be central in supporting the production of innovative therapies in Europe.
In this exclusive Q&A with European Pharmaceutical Review, Sheila Ann Mikhail, co-founder of AskBio and keynote speaker at CPHI Barcelona delves into the current landscape and future potential of the gene therapy sector. She explores strategies for making gene therapies more affordable and accessible, innovations in drug delivery, as well…
CPHI Barcelona takes place in October 2023, covering a wide range of topics from next generation biomanufacturing and formulation to sustainability.
The European Commission has published its much-anticipated proposed revisions to the EU pharmaceutical legislation. While not as extensive as some had anticipated, with elements such as the supplementary protection certificate – the demise of which has been foretold for years – continuing albeit in a different form, Elisabethann Wright, Partner,…
Nicolas Chornet, Senior Vice President of Resilience Operations at Moderna provides insight on how vaccine manufacturers can secure resilience in an environment of rapid technological advancement.
Pharmacovigilance regulation in the EU and beyond has continued to grow and become more stringent over the last decade. In this article, ICON’s Graeme Bones explains how to handle the different types of data migration methods and how companies can select the optimum approach to ensure data integrity is maintained.
NMR relaxometry is a promising technique for identifying pharmaceutical raw materials without the need for laboratory testing. Gregory Webster, Senior Principal Research Scientist at AbbVie, considers the use of NMR relaxometry for identity confirmation of monoclonal antibodies.
Recent breakthroughs in anti-Abeta immunotherapy for Alzheimer's have shown disease-modifying potential, with vaccination emerging as a promising approach, as AC Immune’s Marija Vukicevic, Yves Kremer, Marie Kosco-Vilbois and Andrea Pfeifer explain.
Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring provides an overview of past and present gene therapy development, plus the progress of clinical trials and key challenges in the sector.
A key element of development for new molecular format biological products is to leverage the appropriate analytical tools to enhance product and process understanding throughout the development lifecycle. Here, Ian Anderson, Mostafa Zarei and Qifeng Zhang at Lonza highlight the benefits of using mass spectrometry technologies to accelerate and de-risk product…
Avoiding risk by studying past challenges and the lessons learned can help biotechs navigate the current uncertain macroeconomic climate, says Brandon Fincher, President of Early Stage Development & Testing at the CDMO Cambrex.
The development and regulatory approval of the first autologous CAR T-cell therapies is a huge advance for modern medicine and has been greeted with justifiable excitement. But applications of this technology are still limited, and given the time and cost constraints, more must be done to broaden access to this treatment. Current…
Here, Chief Scientist Bruce Lahn of the CDMO VectorBuilder discusses best practices, common problems, and possible solutions to mitigate risk and free up capacity when developing and designing mRNA therapeutics.
In this Q&A, Laure Pomares Voisin, Quality Director, Catalent Biologics and Tony Cundell Principal Consultant, Microbiological Consulting, LLC discuss some of the key microbiology and environmental monitoring challenges and trends in pharmaceutical manufacturing today.
A key part of Annex 1, due to come into effect on 25 August 2023, is the development of a holistic contamination control strategy (CCS). In this article, EPR’s Caroline Peachey summarises an expert panel discussion, which explored common challenges in implementing a CCS and made several recommendations.