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Single-temperature incubation has been discussed for a long time in the pharmaceutical industry but only a few sites have implemented this system. Here, Guillaume Pinon, Head of the Microbiology Lab at Servier, discusses the use of single-temperature incubation in an aseptic production facility, outlining the regulatory considerations, strategic approach, challenges…
Specialised microbial testing is key in drug development to mitigate contamination risks, which threaten drug efficacy and patient safety. Bruker's MALDI Biotyper® at MPL, Austria, ensures accurate and robust testing, in a high-throughput workflow, delivering reproducible results.
Endotoxin testing continues to evolve alongside the industry’s need for more sustainable methods that reduce ecological impact. Nicola Reid, Associate Director of Endotoxin Products, Charles River Labs, reflects on these developments which are driven by the 3Rs (replacement, reduction and refinement).
In this Guide to Data integrity articles explore the role of data integrity in CCS, AI and ML as well as biopharma manufacturing.
This in-depth focus features articles on single temperature incubation, endotoxin standards and aseptic connections in pharmaceutical manufacturing.
European Pharmaceutical Review Issue 3 includes articles on microbiology, downstream bioprocessing and drug development. Register your details now to download this exclusive content.
Listen to the discussion on contamination risks in biomanufacturing, featuring mycoplasma and virus testing per European Pharmacopoeia and USP standard
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.
Identify molecular contamination concerns in the pharmaceutical workspace and determine the right filtration solution for dealing with these problems.
In sterilisation tunnels the need for filtration is of the utmost importance. Choosing the right filter can have an effect on production yield.
Learn how you can upgrade your filtration choices without compromising on energy performance.
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.
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.
European Pharmaceutical Review Issue 2 includes articles on cell and gene therapy, from supply chain and manufacturing to microbial testing.
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.
