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Guide: Validation of titration methods
This guide explains method validation steps using examples of common titration applications. These include practical hints and recommendations.
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Analytical techniques
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Evolving real-time dissolution prediction and product release
EPR highlights the development of a model to predict dissolution of sustained release formulations based on Raman process analytical technology (PAT) sensor data that could enable real-time release testing.
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Advancing autonomous API reaction optimisation
A novel flow reactor platform was able to self-optimise a range of variables within a multi-step reaction by leveraging process analytical technologies (PAT) and chemometric models.
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Efficient water determination accelerates API development
Contract development and manufacturing services for active pharmaceutical ingredients (APIs) must meet the requirements of customers and regulatory bodies alike. In the process control lab of the CARBOGEN AMCIS AG pilot plant in Bubendorf, Switzerland, accurate and efficient Karl Fischer titration workflows for water determination offer fast and reliable decision…
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Progress in the implementation of biofluorescent particle counters
Despite the promise of biofluorescent particle counters (BFPCs) as an alternative and rapid microbiological method and process analytical technology, their implementation thus far has predominantly occurred in non-GMP environments. In this article, EPR’s Hannah Balfour explores the reasons, with comment from Mike Russ, Senior Manager, Head of QCLS/Analytical Science and…
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A strategic approach to optimisations of testing bacterial endotoxins
Given industry's recent focus on the sustainability of bacterial endotoxin testing (BET), here, AstraZeneca colleagues Miriam Guest, Karen Capper, Dennis Wong and Phil Duncanson share how they worked to establish a short-, mid- and long-term strategy to optimise BET across the global enterprise. They also explore some of the short-term…
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Environmental Monitoring In-Depth Focus 2022
Features in this in-depth focus explore the development of a sustainable approach to bacterial endotoxin testing (BET) within a global enterprise, as well as progress towards the use of biofluorescent particle counters for water bioburden applications.
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European Pharmaceutical Review Issue 4 2022
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,…
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Does terminal sterilisation affect the quality of ophthalmic APIs?
EPR summarises research into the impact of gamma irradiation and ethylene oxide sterilisation treatments on European Pharmacopoeial compliance of common ophthalmic APIs.
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LAMP assays to enable rapid and sensitive detection of BCC
Here, EPR presents a novel loop-mediated isothermal amplification (LAMP) assay developed to enable the rapid and sensitive detection of Burkholderia cepacia complex (BCC) in pharmaceutical manufacturing.
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Whitepaper: Analytical methods for COVID-19 vaccine production
This whitepaper shares how analytical solutions from METTLER TOLEDO can be used to characterise COVID-19 vaccines.
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Whitepaper: Maintain product integrity in biologic clinical studies
Cold chain shipping challenges & root causes of common reference product sourcing problems.
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ebook: Guidance on implementation of ARMMs
Many quality control professionals recognise that the need to modernise microbial detection methods is at an all-time high.
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On-demand webinar: Speed your biologic into phase 1-3 clinical trials
How shortening the timeline from development to clinic can be achieved through parallel processing versus using a task/time compression approach.
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Biopharmaceutical bioseparation systems market to value $20bn
With demand for biopharmaceuticals rising and advances being made in bioseparation systems, the global market it expected to witness significant growth.
