Challenges and solutions to adopting MALDI technology for filamentous fungi ID with emphasis on sample preparation and database development.
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USP and Phlow have built a new laboratory to develop test methods and standards to facilitate broader adoption of continuous manufacturing in the US.
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.
A framework to enable a holistic approach to CCI that assures both primary packaging and process contribute to good CCI of sterile vial product.
According to a new study, Drug Ranking Using Machine Learning (DRUML) can accurately rank cancer therapies by efficacy across a range of cancer types.
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.
This on-demand webinar will provide aspects of a sterility assurance program for a pharmaceutical product. Sterility assurance begins at the early stages of product development and follows through the entire product lifecycle.