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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.
The pharma industry’s adaptation to Industry 4.0 has been slow, due to the extensive regulatory requirements imposed on manufacturers. However, regulatory agencies are starting to embrace movement towards more rapid/automated systems, as illustrated in the revised EU GMP Annex 1, which entered into force in August. Here, Isabella Jul-Jørgensen from the Technical…
In this in-depth focus are articles on reducing production time for allogenic CAR T-cell therapies and the complexities of mRNA development, from design intricacies to scalability.
In this in-depth focus, explore how automation is transforming environmental monitoring in line with Annex 1, implementation of contamination control strategies and discover the emerging trends and challenges in pharmaceutical microbiology.
Dave Elder explores evolving concerns surrounding nitrosamine-related impurities while calling for continued collaboration to harmonise regulatory approaches.
EPR Issue 4 includes articles on fridge-free vaccines, dry powder drug delivery, Annex 1, contamination control strategy and more.
