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Is PSS Insourcing Solutions right for you?
Patricia Grace, Senior Director, Eurofins Professional Scientific Services (PSS) Europe, shares reasons for the success of the model within the bio/pharma industry.
List view / Grid view
Microbiology
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Developing and delivering live biotherapeutic products
The microbial content of the gut has a well established role in health and disease. In this article, European Pharmaceutical Review’s Hannah Balfour explores the development and formulation of live biotherapeutic products (LBPs), an emerging treatment modality that seeks to capitalise on the interaction between the microbiota and host in…
whitepaper
Press release: Telstar: 360 degrees GMP consultancy & engineering solutions at CPhI
Telstar promotes innovative aseptic production solutions in a setting marked by the new GMP Annex 1.
news
Why is there no standard MALDI-TOF MS procedure for bacterial identification?
Here, EPR summarises a review outlining how different sample preparation protocols, culture media and conditions affect MALDI-TOF MS identification of bacteria.
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Do we need gloves? Cleanroom dressing processes may not, finds study
Research indicates, with robust handwashing protocols, there is no difference in cleanroom garment bacterial contamination with or without gloves in the dressing process.
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Is your microbial air sampler fit for purpose?
Here, EPR summarises Tim Eaton’s explanation of the importance of assessing biological collection efficiency when selecting an air sampler.
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On-demand webinar: Spores in my cleanroom
This webinar considers the problems bacterial and fungal spores present for contamination control and remediation and disinfection strategies.
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New FDA draft guidance on microbiological quality of NSDs
The draft guidance discusses product development considerations, risk assessments and cGMPs relevant to microbiological control in non-sterile drug (NSD) manufacturing.
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Biological safety cabinet safest place for parenteral product compounding, says study
Researchers recommend the biological safety cabinet be used whenever possible to compound parenteral products in a clinical setting.
whitepaper
Whitepaper: Best practices in environmental monitoring
This whitepaper outlines the important components of an environmental monitoring programme, providing practical advice and best practice guidance.
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Data integrity is a key concern with microbial methods, says expert
Dr Tim Sandle explains that, whether rapid or conventional, documented on paper or computer, microbial methods must have data integrity.
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Scrubbing up the environment
Here, colleagues from University Hospitals Bristol and Weston NHS Foundation Trust (UHBW) share the beneficial impact of reduced cleanroom environmental contamination following an upgrade to their facilities and procedures.
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Bacterial Endotoxin Test using LAL methodology: overcoming interfering factors
The Bacterial Endotoxin Test, using LAL methodology, is a key in-process and final product release test for sterile pharmaceuticals and medical devices. One of the challenges with LAL methodology is overcoming interfering substances as demonstrated by inhibition or enhancement of an endotoxin challenge. Here, Bio Products Laboratory’s Dr Tim Sandle…
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Flow cytometry to advance decontamination and sterilisation processes
A new paper reveals how combining flow cytometry with other analytical techniques can provide a wealth of information on bacterial viability and thus enhance sterilisation processes.
news
Infrared thermography can detect pre-visual bacterial growth, shows study
A new paper shows thermal imaging (infrared thermography) can detect E. coli and S. aureus bacteria after just six hours of incubation, long before it is visible to the human eye.
