New mass spectrometry Chapter could “revolutionise” biopharma quality assurance
Launch of the USP general method chapter signals a breakthrough in pharmaceutical drug impurity control, according to biopharma experts.
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Launch of the USP general method chapter signals a breakthrough in pharmaceutical drug impurity control, according to biopharma experts.
European Pharmaceutical Review’s latest Pharma Horizons report provides insight on key sustainability developments in the pharmaceutical industry and covers topics including regulation, manufacturing and clinical development.
The innovative method uses spectroscopy and could enhance pharmaceutical quality assurance in resource-limited settings, the study suggests.
Mike King, Senior Director, Product & Strategy (Quality, Regulatory, Safety & Detect), Digital Products & Solutions at IQVIA and Alex Denoon, Partner at Bristows Law Firm, explore the challenges of implementing the EU AI Act and the impact of GDPR requirements in life sciences.
The system is distinguishable from other bacterial expression systems and can be applied in scenarios where minimal endotoxin contamination is an issue, according to the research.
Analysis cites personalised medicine, outsourcing and digitalisation as some of the key factors set to advance the pharmaceutical analytical testing market to 2032.
The new approach involving refinement and optimisation of ionisable lipids could accelerate the development of mRNA therapies, research suggests.
Julie Huynh, Research and Development Manager, Gelteq, explores the potential of gel-based oral drug formulations for alleviating dysphagia and highlights the company’s approach to overcoming key challenges in this area, like administration.
Charles River’s Courtney Wachtel and Sherri Hopple discuss endotoxin cartridge testing, its application and how it differs from traditional BET assays.
By automating and simplifying hydration of media, feeds and buffers, the Oceo Rover system enables manufacturers of biopharmaceuticals to improve process consistency and speed time-to-market. Here, Guy Matthews, Director of Single-Use Technology for FUJIFILM Irvine Scientific, shares more about this transformative hydration solution.
This in-depth focus features articles on environmental monitoring trends such as digitalised management of EM data, as well as endotoxin detection.
European Pharmaceutical Review Issue 5 includes articles on bioprocessing, biologics, sustainability, and drug formulation.
With fluorescence imaging an essential tool in noninvasive biomedical research, the microscopy advancement holds opportunity for progress in optical imaging, according to the paper.
With a growing pipeline of biologics, increase in vaccine production, and small batch sizes targeting small patient populations, there’s increasing demand for advanced manufacturing tech.
The collaboration between Novartis Pharma AG and Ratio Therapeutics aims to advance a potential best-in-class therapeutic candidate as a treatment for a difficult-to-treat cancer.