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Semi-automatic method could provide “superior” bacterial characterisation analysis
The analysis technique offers “significant” advantages over traditional colony forming unit (CFU) counts, according to the paper.
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Microbiology
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Improving aseptic connections throughout the manufacturing process
As companies are adapting to EU GMP guidelines for Annex 1 - Manufacture of Sterile Medicinal products, there have been numerous discussions involving the terms sterile and aseptic, as if they were synonymous. Vanessa Vasadi Figueroa, Chief Microbiologist at VVF Science® and Executive Director of Microbiology & Sterility Assurance at…
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Cleanroom microbiology: single-temperature incubation for EM
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…
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Advertorial: Next-generation microbial testing of pharmaceuticals
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.
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Application note: Automated nucleic acid amplification assay for mycoplasma detection in cell and gene therapy products
Ambili Menon, Pharma Quality Control, bioMérieux Inc. addresses the task of microbiological testing for advanced therapeutic medicinal products.
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Application note: Validating recombinant cascade reagents in 3 simple steps
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).
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Guide to Data Integrity 2024
In this Guide to Data integrity articles explore the role of data integrity in CCS, AI and ML as well as biopharma manufacturing.
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QA/QC Microbiology In-Depth Focus 2024
This in-depth focus features articles on single temperature incubation, endotoxin standards and aseptic connections in pharmaceutical manufacturing.
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European Pharmaceutical Review Issue 3 2024
European Pharmaceutical Review Issue 3 includes articles on microbiology, downstream bioprocessing and drug development. Register your details now to download this exclusive content.
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Webinar: Overcoming contamination risks during biologicals production: Mycoplasma & virus testing
Listen to the discussion on contamination risks in biomanufacturing, featuring mycoplasma and virus testing per European Pharmacopoeia and USP standard
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Enhancing oral drug delivery: Exploring multiparticulate systems
11 June 2024 | By ThermoFisher Scientific
Explores the benefits and uses of multiparticulate systems in oral drug delivery and how they can help address challenges faced by traditional dosage forms.
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Case Study: Franz Ziel’s utilisation of Enzyme Indicators using Fractional Kill Time method
3 June 2024 | By
An EJPPS published study on Enzymatic Indicators in Vaporized Hydrogen Peroxide Decontamination Cycles: Application-related Research focusing on Fractional Kill Time (FKT) and Reverse Fractional Kill Time (RFKT) Studies
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Ensuring sterility of a novel anti-VEGF bispecific antibody
Safety of the compounded biologic was confirmed following 28-day storage in two different polypropylene syringe types, research shows.
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Alternative methods for mycobacterial testing in biological products
Considering the limited available information on implementing mycobacterial testing for quality control of biologicals, researchers have highlighted a suitable potential alternative detection method.
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Rapid method for whole-genome fungal ID
The novel technique for whole-genome analysis of fungal species is “highly suitable” for quality and safety monitoring of medicinal materials, the paper suggests.
