All Sterility and rapid methods articles – Page 5
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WhitepaperApplication Note: Automated Set-Up of the PyroGene® rFC Assay
Automating the pipetting steps of the PyroGene® rFC Assay on the ASSIST PLUS helps to reduce the opportunity for pipetting errors and ensures robust reproducibility.
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NewsUSP recommends revisions to proposed RMM chapters
Revisions for two proposed USP chapters recommend changes for rapid tests required for releasing sterile short-life products, as well as for rapid microbiological methods (RMM) for detecting contamination in these products.
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Webinar
Are outdated microbial identification methods risking your product safety and operational efficiency?
Watch this webinar to unravel the complexities of microbial identification technologies and their pivotal role in fortifying contamination control strategies within the pharmaceutical industry.
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NewsRapid microbiology testing market to value nearly $13bn by 2034
Driven by a rise in infectious diseases and advancements in digital technologies, increased demand for rapid microbiology testing is set to accelerate the market’s growth.
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NewsBiosensing technique promising for whole-genome detection
The bacterial detection method is robust and highly sensitive over a wide concentration range and does not require DNA amplification, research suggests.
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ReportPharma Horizons: Artificial Intelligence
EPR’s inaugural Pharma Horizons report explores the latest advances in artificial intelligence (AI) and machine learning (ML) for drug development, pharmaceutical manufacturing and quality control.
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NewsWill new therapeutic agent replace antibodies for bacterial detection?
Aptamers offer a “cutting-edge approach” for identifying gram-negative bacterial pathogens, a paper suggests.
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Webinar
Applying ISO/TR 14644-21 - Airborne particle sampling techniques
Watch this webinar as GMP expert Mark Hallworth discusses the difference between cleanroom classification and monitoring of the new ISO 14644 Technical Report 21 focuses in section 4.0 and 5.2.
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VideoVideo: Unveiling the science behind NGS
Virtual seminar presented by Christine Farrance, PhD, Senior Global Scientific Affairs Liaison of Microbial Solutions at Charles River designed to improve your understanding of how to leverage NGS to analyze the entire genome and mixed samples in a single, efficient test to identify, classify, and understand microbes in mixed and ...
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ArticleDeveloping micro QC for ATMPs
In this Q&A, Natalie Saunders, Interim Head of Quality Control at CGT Catapult, delves into the advancements and challenges in microbiological QC for cell and gene therapies. She discusses rapid sterility testing methods, regulatory frameworks, and the impact of automation and digitalisation on quality control.
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ArticleBioburden and sterility testing: how to conserve gene therapy product
Here, Kathy Zagaroli, Senior Director of Quality Control at Kiniksa Pharmaceuticals, and Tom Bujold, Senior Director of Quality Control at REGENXBIO, discuss the challenges of bioburden and sterility testing for gene therapies and why industry must come together to drive increased harmonisation.
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ArticleYear in review: EPR’s top stories of 2023
EPR wraps up the year with a selection of top stories from 2023, highlighting key trends and topics such as environmental monitoring (EM), quality (QA/QC), manufacturing, regulation and clinical development.
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NewsInnovative technologies facilitate novel contamination-detection method
A new 24-hour sterility testing method combining nanopore sequencing and machine learning could revolutionise sterility assurance in biopharmaceutical manufacturing of cell therapies.
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Whitepaper
Application note: Equivalency of PCR-based rapid sterility testing and the compendial culture method
Sterility testing is a critical component of release testing for any cell therapy product since microbial contamination of cell therapy products can potentially kill recipients.
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Whitepaper
Whitepaper: The value and benefits of rapid mold detection in the pharmaceutical industry
Address the importance of accurate microbial identifications and proper contamination control for effective mold remediation.
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Whitepaper
Application note: Role of in-house isolates in pharmaceutical quality control
This application note addresses the need to evaluate key sources of contamination to maintain an optimum level of pharmaceutical quality control.
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WhitepaperProduct hub: Rapid mold detection in as little as one day
Quick to spread and difficult to detect, molds can compromise a facility in the time it takes to confirm their presence. The RMBNucleusTM Mold Alarm signals at the first sign of mold detection.
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ArticleQA/QC & Microbiology In-Depth Focus 2023
This microbiology in-depth focus, explores sterility and bioburden testing considerations for cell and gene therapies.
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NewsNew method could replace microbiology CFU assay
A new, more efficient colony counting method called the Geometric Viability Assay (GVA) could enable microbiologists to test potential new drugs such as antibiotics more quickly.
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ArticleEuropean Pharmaceutical Review Issue 5 2023
EPR Issue 5 includes articles on microbiological testing of ATMPs, the use of inline Raman spectroscopy for bioprocess control, paediatric drug formulation, and more.