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Pharma Horizons: leading-edge formulation
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
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Articles
Titanium dioxide (E171) and its role in formulation
In this article Mike Tobyn from Bristol Myers Squibb, Jonathan Kaye from GSK, David Harris from MSD and Eli Lilly’s Jason Melnick discuss the role of E171 (titanium dioxide) in the identification of solid oral dosage forms.
Recommendations and considerations for bacteriophage therapy usage in clinical settings
Phage therapy holds great promise as a new therapeutic option in the face of increasing antimicrobial resistance, but sound clinical data remains a stumbling block to its application. Here, Snehit Satish Mhatre from Eurofins Biopharma Product Testing outlines key considerations to address when designing clinical trials.
Guide to Data Integrity
Welcome to EPR's Guide to Data Integrity. In this edition, Charles River explores the significance of data integrity in pharmaceutical manufacturing, Graeme Bones of ICON considers how to complete database transfer with data integrity considerations at the forefront and Rapid Micro Biosystems® discusses the practical implications of the ‘four-eyes principle’ for pharma…
Formulation In-Depth Focus 2023
This in-depth focus features articles on trends in capsule formulation and the evolving role of titanium dioxide in formulation.
International regulation: the importance of quality assurance in drug development
Raquera Brown, Executive Director of Quality at Zymeworks offers quality and compliance professionals advice on how to navigate the often-complex regulatory space during development of innovative drugs like antibody therapeutics.
In Depth Focus QA/QC Microbiology/RMM 2023
This in-depth focus explores collaborative efforts to accelerate validation and adoption of rapid microbial methods across the pharmaceutical industry and the power of rapid methods for fungal ID.
Reflecting on five years of quality control for nitrosamine impurities
Since the US Food and Drug Administration (FDA)’s report on a series of nitrosamine-related impurity drug recalls in 2018, pharma has made great strides in its ability to detect and control for these impurities. Dr Mrunal Jaywant, Vice President of R&D at USP India proposed a collaborative, cross-community approach between…
Microbiome therapies: a maturing movement
On World Microbiome Day 2023, Hervé Affagard, CEO and co-founder of MaaT Pharma and Jeffrey Silber, Chief Medical Officer of Vedanta Biosciences delve into the current innovative landscape of microbiome-based therapeutics.
European Pharmaceutical Review Issue 3 2023
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 …
AMR certification: recognising responsibly in antibiotic manufacture
Following the recent launch of the BSI’s AMR certification, EPR invited Steve Brooks from the AMR Industry Alliance and BSI’s Courtney Soulsby to elucidate its significance for antibiotic manufacturers and the wider pharma industry.
Digitalisation of the clinical trial landscape
UCB Pharma's Chief Medical Officer Iris Loew-Friedrich, shares her perspective on digital innovation in clinical trials plus current challenges in clinical data management and how it could evolve in the future.
New quality requirements for tobacco products
Here, Dave Elder explores proposals for new FDA rules on tobacco product manufacturing. How could strategies for controlling tobacco-specific nitrosamines compare with those for nitrosamine drug substance-related impurities?
The cell and gene therapy CDMO bottleneck isn’t capacity – it’s capability
CDMOs have been squeezed by the sharp increase in companies preparing to scale their cell and gene therapy manufacturing for Phase III trials and commercialisation, and physical capacity has been a common scapegoat. But eXmoor CEO Angela Osborne says the real limiting factor is experience.
Overcoming bottlenecks in the advanced therapy supply chain
Professor Dr Martin Bornhäuser of University Hospital Carl Gustav Carus Technische Universität Dresden discusses the cell therapy bottleneck and why advanced therapy tracking systems could offer a solution.
Recent developments in stem cell therapies
EPR explores recent developments in stem cell therapies across several hard-to-treat diseases and how technology is transforming ATMP manufacture.
