European Pharmaceutical Review's latest journal features articles discussing the challenges and potential of antibody-drug conjugates, innovations in cleanroom infrastructure and why we need to test for heavy metal contaminants in cannabis vaping aerosols. Also in the issue, an exploration of how risk-sharing strategies could help expedite access to COVID-19 vaccines,…
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Challenges and solutions to adopting MALDI technology for filamentous fungi ID with emphasis on sample preparation and database development.
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.
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.
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.
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.
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.
Key requirements to ensure patient safety in the present-day development and production of viral vaccines, and the challenges going forward.
Product characterisation facilitates easier process design to ensure the biological drug attains critical product safety, purity, and potency.