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QA/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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Microbiology
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New 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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European 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.
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Video: Ami Polymer: Setting new bioprocessing standard
Our dedication to quality and prompt service has earned us several awards. You can trust us for top-notch service and reliability.
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Antibiotics ‘no longer effective’ for childhood infections, finds study
Australian-led study highlights ‘alarmingly high’ rates of resistance to commonly-prescribed antibiotics in the Asia-Pacific region.
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Under the microscope: QC compliance and environmental isolates
In this Q&A Microbiologics’ Brianna DeWitt explores how to make QC with environmental isolates simple and reliable while conquering compliance with regulations and standards.
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Starvation stress key in Micrococcus luteus cleanroom survival
Key factors behind the lengthy survival capabilities of the bacterium Micrococcus luteus (M. luteus) within a cleanroom have been reported in Tim Sandle’s recent paper.
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Study reports rapid method for microbial contaminant detection
Research using fluorescent optical respirometry (FOR) illustrated successful detection of aerobic bacteria three hours after setting samples.
webinar
Navigating challenges in HPAPI development and manufacturing
12 October 2023 | By Thermo Fisher Scientific (Patheon)
HPAPIs now account for more than half of clinical small molecule NCE drugs. Learn from our experts how to overcome the most common challenges in HPAPI handling.
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How to implement single temperature incubation in your environmental monitoring routine
11 October 2023 | By bioMérieux
Watch this webinar to hear Laurent Leblanc explore the challenges and benefits of implementing the “one media / one temperature” approach for routine environmental monitoring.
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RMMs and endotoxin testing: efficiency gains and regulatory perspectives
13 September 2023 | By Veolia Water Technologies & Solutions, Sievers Instruments
Learn how Rapid Microbiological Methods can provide results in less than 45 minutes and endotoxin assays can be set up in less than 10 minutes to improve contamination control and reduce risk.
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Uncovering new frontiers in microbiology and EM
In this Q&A, Laure Pomares Voisin, Quality Director, Catalent Biologics and Tony Cundell Principal Consultant, Microbiological Consulting, LLC discuss some of the key microbiology and environmental monitoring challenges and trends in pharmaceutical manufacturing today.
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Novel strategy could facilitate rapid online-endotoxin monitoring
An innovative, chemosensor-based method for detection of lipopolysaccharide (LPS) is set to facilitate development of a rapid online-endotoxin monitor.
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Technical document: Introducing: Ami Polymer’s Sterile Sampling Systems
Next-Gen Sterile Sampling System: Pinnacle Compliance - USP Standards 87, 88, 85, 661.1, 788, 71, and ISO 11737-1 for Unparalleled Pharma & Biopharma
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Leveraging PAT for environmental monitoring in light of Annex 1
The pharma industry’s adaptation to Industry 4.0 has been slow, due to the extensive regulatory requirements imposed on manufacturers. However, regulatory agencies are starting to embrace movement towards more rapid/automated systems, as illustrated in the revised EU GMP Annex 1, which entered into force in August. Here, Isabella Jul-Jørgensen from the Technical…
