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European Pharmaceutical Review Issue 3 2024
European Pharmaceutical Review Issue 3 includes articles on microbiology, downstream bioprocessing and drug development. Register your details now to download this exclusive content.
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QA/QC
news
New US fill finish facility receives $4.1 billion investment
Novo Nordisk plans to allocate $6.8 billion towards production to expand its overall US manufacturing capacity.
podcasts
EPR Podcast Episode 26 – Navigating Nitrosamine Impurities – Jason Brown, Adare Pharma Solutions
In this podcast, Jason Brown, Senior Manager, Analytical Sciences, R&D, Adare Pharma Solutions, discusses the current landscape and the best approaches for mitigating contamination and detecting nitrosamines.
news
Press Release: Overcoming contamination risks during biologicals production: Mycoplasma & virus testing
SGS’s Birsfelden, Switzerland lab is now a “one-stop shop” for biopharma firms in GMP/non-GMP analytics, featuring a new stability studies capability.
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SFC-MS: advancements and applications in pharmaceutical quality control
Modern supercritical fluid chromatography systems coupled with mass spectrometry are empowering pharmaceutical quality control laboratories. Here, Hugues Jambo, Cédric Hubert, Éric Ziemons and Philippe Hubert from the Laboratory of Pharmaceutical Analytical Chemistry at the University of Liège discuss applications from impurity and nitrosamines detection to purity analysis.
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Webinar: Overcoming contamination risks during biologicals production: Mycoplasma & virus testing
Listen to the discussion on contamination risks in biomanufacturing, featuring mycoplasma and virus testing per European Pharmacopoeia and USP standard
webinar
Enhancing oral drug delivery: Exploring multiparticulate systems
11 June 2024 | By ThermoFisher Scientific
Explores the benefits and uses of multiparticulate systems in oral drug delivery and how they can help address challenges faced by traditional dosage forms.
whitepaper
Case study: Data-driven water system maintenance
This case study looks at how an online microbial analyzer provides real-time bioburden monitoring for rapid response to adverse water system events.
news
Eli Lilly selects new EVP of Global Quality
The new Executive Vice President (EVP) has over “25 years of experience and a proven track record of leading strategic quality initiatives”, Eli Lilly and Company shared.
whitepaper
Case Study: Franz Ziel’s utilisation of Enzyme Indicators using Fractional Kill Time method
3 June 2024 | By
An EJPPS published study on Enzymatic Indicators in Vaporized Hydrogen Peroxide Decontamination Cycles: Application-related Research focusing on Fractional Kill Time (FKT) and Reverse Fractional Kill Time (RFKT) Studies
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Pharma Horizons: Cell and Gene Therapy
This report is dedicated to exploring some of the latest innovations in the cell and gene therapy space, from development and quality control, through to manufacturing and clinical trials.
news
Innovative analytical method for quality control of nanomedicines
The research on nanomedicines investigated the intrinsic radiothermal emission of nanodrugs using a novel method.
article
ICH Q14 – latest guideline on analytical procedure development
Here, Dave Elder delves into the newly issued ICH Q14 guidance on analytical procedure development, discussing its impact during commercial phases as well as clinical development.
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Effective data quality governance: challenging five common myths
It is a well-established expectation that regulatory processes will become increasingly data focused, which places a new urgency on data quality governance in the pharmaceutical industry. In this Q&A Steve Gens and Preeya Beczek present a pragmatic view of what is involved.
news
EMA recommends suspension of hydroxyprogesterone caproate medicines
The recommendation comes after studies raised possible safety concern and found 17-OHPC is not effective in preventing premature birth.
