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Dave Elder shares industry thoughts on an ICH Q6(R1) concept…
Dave Elder shares industry thoughts on an ICH Q6(R1) concept paper that aims to revise general principles for uniformity and consistency across ICH Q6 guidelines for test criteria and specifications.
European Pharmaceutical Review Issue 5 includes articles on bioprocessing, biologics,…
European Pharmaceutical Review Issue 5 includes articles on bioprocessing, biologics, sustainability, and drug formulation.
European Pharmaceutical Review Issue 4 includes articles on regulation, bioproduction,…
European Pharmaceutical Review Issue 4 includes articles on regulation, bioproduction, environmental monitoring, packaging and drug delivery.
European Pharmaceutical Review Issue 3 includes articles on microbiology, downstream…
European Pharmaceutical Review Issue 3 includes articles on microbiology, downstream bioprocessing and drug development. Register your details now to download this exclusive content.
European Pharmaceutical Review Issue 2 includes articles on cell and…
European Pharmaceutical Review Issue 2 includes articles on cell and gene therapy, from supply chain and manufacturing to microbial testing.
In this article, Dave Elder delves deeper into some ongoing…
In this article, Dave Elder delves deeper into some ongoing developments in topic areas highlighted in European Pharmaceutical Review (EPR) during 2023.
EPR Issue 5 includes articles on microbiological testing of ATMPs,…
EPR Issue 5 includes articles on microbiological testing of ATMPs, the use of inline Raman spectroscopy for bioprocess control, paediatric drug formulation, and more.
Dave Elder explores evolving concerns surrounding nitrosamine-related impurities while calling…
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…
EPR Issue 4 includes articles on fridge-free vaccines, dry powder drug delivery, Annex 1, contamination control strategy and more.
EPR Issue 3 includes articles the role of titanium dioxide…
EPR Issue 3 includes articles the role of titanium dioxide in pharmaceutical formulations, bioprocessing innovations for cell and gene therapies, manufacturing of radiotheranostics and more …
EPR Issue 2 includes articles on the future of cell…
EPR Issue 2 includes articles on the future of cell and gene therapy, the potential of AAV gene therapies, NMR relaxometry and more…
While determining active intakes and control strategies for short chain…
While determining active intakes and control strategies for short chain alkyl N-nitrosamines was relatively easy to establish, nitrosamine drug substance-related impurities continue to present challenges. Here, Dave Elder reflects on the three main instances of nitrosamine contamination in drug products.
EPR Issue 1 includes articles on the future of pharmaceutical…
EPR Issue 1 includes articles on the future of pharmaceutical microbiology, separation and purification of complex biologics, the latest on nitrosamines and more...
In EPR Issue 5, articles explore the role of whole…
In EPR Issue 5, articles explore the role of whole genome sequencing in pharmaceutical microbiology, the formulation of oral taxanes and the potential for tackling immune-mediated disease with CAR T regulatory cells. Plus, coverage of how proposed US pharmaceutical regulation could impact European companies, in-house lentiviral vector manufacturing and much…
In EPR Issue 4, experts discuss implementing a global strategy…
In EPR Issue 4, experts discuss implementing a global strategy to improve the sustainability of endotoxin testing, how to accelerate timelines for manufacture of multi-specific antibodies and the potential of oncolytic viruses as a therapy for glioblastoma. Also featured: progress towards smart vaccine manufacturing, an update on edible anticounterfeiting technology,…
