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Pharma Horizons: Cell and Gene Therapy
This report is dedicated to exploring some of the latest innovations in the cell and gene therapy space, from development and quality control, through to manufacturing and clinical trials.
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Environmental Monitoring
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Whitepaper: Molecular contamination control – odours, gases and toxics
Identify molecular contamination concerns in the pharmaceutical workspace and determine the right filtration solution for dealing with these problems.
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Whitepaper: High-temperature filters for sterilization and depyrogenation processes
In sterilisation tunnels the need for filtration is of the utmost importance. Choosing the right filter can have an effect on production yield.
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Booklet: Air Filtration – Upgrades without compromise
Learn how you can upgrade your filtration choices without compromising on energy performance.
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Under the microscope: Using recombinant reagents for BET
Veronika Wills, Associate Director, Global Technical Services at Associates of Cape Cod, Inc (ACC), discusses in-depth, motivations and strategies surrounding the use of recombinant reagents for bacterial endotoxin testing.
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Application note: Isokinetic microbial air sampling on MAS-100 instruments
Microbial air sampling in controlled environments should be performed isokinetically. The following text explains the isokinetic sampling process using MAS-100 instruments with a flow rate of 100 L/min and compares it with sampling at a lower flow rate of 25 L/min.
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European Pharmaceutical Review Issue 2 2024
European Pharmaceutical Review Issue 2 includes articles on cell and gene therapy, from supply chain and manufacturing to microbial testing.
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Testing of Rapid Microbiological Methods (RMMs) – Demonstrating Equivalence to Existing Methods in Alignment with USP <1223>
26 April 2024 | By Veolia Water Technologies & Solutions - Sievers Analytical Instruments
Watch this on demand webinar to hear about the latest RMM technology and how it aligns with USP testing criteria. This webinar will cover testing strategy, and data will be presented to effectively demonstrate suitability of the Soleil for its intended use and correlation to plate counts.
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Microbe-carrying particle recovery efficacy with manual surface sampling
Three different contact plate methods were tested to determine a convenient manual surface sampling technique for microbial contamination recovery, the paper explained.
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Study monitors particles and falling bacteria in biosafety cabinets
The type of clothing worn in aseptic manufacturing areas may impact the number of particle and airborne bacteria detected in biosafety cabinets.
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Widening adoption of animal-free reagents for endotoxin testing
If the proposed USP Chapter < 86 > on using non-animal derived reagents is approved, it will be published for early adoption in November 2024, USP states.
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EP monographs allow rFC for water testing
As of 1 April, two European Pharmacopoeia monographs allow the use of rFC to test for bacterial endotoxins in pharmaceutical waters.
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Endotoxin testing: the international regulatory landscape
In this extract from EPR’s Pharma Horizon’s report, Evelyn Der, Lindsey Silva and Carmen Marín Delgado de Robles from Roche Group discuss the regulatory guidelines for bacterial endotoxin testing and the move towards adoption of recombinant methods.
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Pharmaceutical environmental monitoring market to value $38.1b by 2030
Technological solutions such as real-time monitoring could help expand the pharmaceutical environmental monitoring market up to the next decade, research says.
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Comprehensive evaluation of Growth Direct® Rapid Sterility for microorganism detection
22 March 2024 | By Rapid Micro Biosystems
Discover the extensive panel testing done to evaluate the new, innovative sterility testing platform, Growth Direct® Rapid Sterility.
