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12 April 2021 | By Charles River Laboratories
Join us on 1 June at 15:00 BST, as Jordi Iglesias visually summarise the ICH Q9 Quality risk management GMP document and explain how you can use the approach and tools described to proactively improve your microbiological QC assays in terms of data integrity.
Researchers have developed a novel sensor, known as a time-temperature indicator, that could be used to monitor the storage conditions of mRNA vaccines.
The life sciences industry may have been slower than other markets to appreciate the benefits of holistic data and document management, but that is changing rapidly now. Here, life sciences data and content management visionaries Steve Gens of Gens & Associates, Remco Munnik of Iperion and James Kelleher of Generis…
This paper takes a closer look at plastic storage bags for bioprocesses focusing on a shift from multilayer to single-layer storage solutions.
A framework to enable a holistic approach to CCI that assures both primary packaging and process contribute to good CCI of sterile vial product.
25 March 2021 | By Thermo Fisher Scientific
Join Thermo Fisher’s Nicola Gardner to learn how a complete, integrated laboratory software system provides streamlined processes and drives data integrity, advancing organisations toward a Pharma 4.0 strategy.
Glenn Abood, founder and CEO of rfxcel, explains how real-time environmental monitoring can combat supply chain shortcomings, providing companies with level of data integrity, traceability, transparency and security that is virtually beyond reproach.
22 March 2021 | By Bruker Biospin Group
In this virtual roundtable, experts explore the uses of nuclear magnetic resonance (NMR) in the analysis of biologics and biosimilars and discuss how recent advances are changing the game.
This whitepaper considers the latest EU GMP Annex 1 draft and its impact on the control and release of sterile products.
Disinfectants must be qualified on the surfaces in a pharmacopeial manufacturing environment prior to use in the facility. Building a study with robust parameters and avoiding common pitfalls is critical to avoid negative responses from regulatory agencies.
The EMA’s drug safety committee concluded that the vaccine is not associated with an increased risk of thromboembolic events and that its benefits still outweigh its risks.
Replacing traditional moisture analysis methods with a rapid, analytical and non-destructive method to improve the quality of freeze-dried product.
A fast, high-resolution, and reproducible reverse phase HPLC method using the BIOshell™ A400 Protein C4 column to analyse the intact mAb Trastuzumab.
What is dissolution testing, why is it critical, what to consider for your method validation? Learn more in this quick guide.
Recent technological advances have made it easier to cope with the complexity of mass spectrometry (MS) based glycan analysis.
