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European Pharmaceutical Review Issue 4 2023
EPR Issue 4 includes articles on fridge-free vaccines, dry powder drug delivery, Annex 1, contamination control strategy and more.
List view / Grid view
Microbiology
whitepaper
Report: Accelerate the RMM validation process
To address the perceived barrier to entry for rapid microbiological methods, new validation packages are now available for Celsis® rapid microbial detection.
whitepaper
Whitepaper: Sustainable microbial monitoring
This white paper looks at the environmental impact of plate count testing and how on-line microbial detection supports sustainable pharma manufacturing.
webinar
Advantages of automated microbial colony counting
16 August 2023 | By Rapid Micro Biosystems
Watch this webinar with independent microbiology expert Dr Tim Sandle to explore the different technologies, regulatory concerns and validation requirements for automated colony counting methods.
whitepaper
ebook: Key biomarkers of immunomodulation
Altasciences has published an ebook sharing comprehensive information about testing biomarkers of immunomodulation as part of your drug development program.
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Video: The EU Annex 1 Good Manufacturing Process (GMP) updated requirements
How the GMP requirements affect the manufacturing of sterile medicinal products from European Member States and products imported from outside Europe.
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The power of rapid methods for fungal ID
By leveraging rapid identification techniques, pharmaceutical facilities can enhance their ability to detect and mitigate fungal contamination, safeguarding product quality and patient safety. Here, Dr Tim Sandle explores key challenges associated with fungal contamination in cleanrooms, discusses conventional and rapid identification methods, as well as the importance of validation.
news
ISO publishes standard on bacterial endotoxin testing
Evaluation of bacterial endotoxin pyrogens is included in the International Organization for Standardization (ISO)’s new standard for microbiological methods.
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In Depth Focus QA/QC Microbiology/RMM 2023
This in-depth focus explores collaborative efforts to accelerate validation and adoption of rapid microbial methods across the pharmaceutical industry and the power of rapid methods for fungal ID.
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Microbiome therapies: a maturing movement
On World Microbiome Day 2023, Hervé Affagard, CEO and co-founder of MaaT Pharma and Jeffrey Silber, Chief Medical Officer of Vedanta Biosciences delve into the current innovative landscape of microbiome-based therapeutics.
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European Pharmaceutical Review Issue 3 2023
EPR Issue 3 includes articles the role of titanium dioxide in pharmaceutical formulations, bioprocessing innovations for cell and gene therapies, manufacturing of radiotheranostics and more …
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Video: An introduction to Protak Scientific and Enzyme Indicators for advanced, gaseous bio-decontamination validation
The advanced rapid validation tool for measuring hydrogen peroxide bio-decontamination performance that’s transforming the validation process in pharmaceutical manufacturing and other applications including healthcare and research.
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Case study: Eliminating contamination with whole genome sequencing
Read this case study to learn how a pharmaceutical company used Accugenix Whole Genome Sequencing for bacterial and fungal ID.
news
How effective is nanopore sequencing for fungal identification?
A paper has described a DNA metabarcoding workflow that rapidly characterises fungal microbiota with high taxonomic resolution.
news
Why is microbiological testing in medical device manufacturing important?
Careful planning during manufacture means accurate microbiology testing methods can be developed, ensuring the safety and efficacy of medical devices, a paper reports.
