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European Pharmaceutical Review Issue 4 2024
European Pharmaceutical Review Issue 4 includes articles on regulation, bioproduction, environmental monitoring, packaging and drug delivery.
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bioMérieux
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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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Next-Generation Rapid mRNA Vaccine CQA Analytics
4 January 2024 | By bioMérieux
Watch this webinar on demand to learn how InDevR and their VaxArray multiplexed immunoassay platform empower Critical Quality Attribute (CQA) testing for multivalent mRNA vaccines.
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Application note: Role of in-house isolates in pharmaceutical quality control
This application note addresses the need to evaluate key sources of contamination to maintain an optimum level of pharmaceutical quality control.
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Application note: Low Endotoxin Recovery case study
This case study discusses the Low Endotoxin Recovery (LER) phenomenon in the drug testing and mitigation approach using the ENDO-RS® kit and ENDOLISA® assay for detecting endotoxin interference
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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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Whitepaper: rFC adoption for bacterial endotoxin testing
What is driving the adoption of rFC for BET? Alternative methods are the obvious sustainable solution for efficient manufacturing.
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bioMérieux
6 December 2022 | By
Founded in 1963 by industry experts in diagnostics solutions, BioMérieux is a multi-generation solution provider of microbiological testing systems. As a global pioneer with an unrelenting spirit to improve upon public health and safety, our mission is to provide the food and pharmaceutical industries with innovative, precise technologies that help…
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Application note: Tipping point – what is driving the adoption of rFC for bacterial endotoxin testing?
As industry leaders seek strategies to build supply chain resilience, multi-sourcing is driving the adoption of alternative solutions like rFC.
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Validation and implementation of a novel automated PCR technology for mycoplasma testing
22 September 2022 | By bioMérieux
This on-demand webinar presents the regulatory submission strategy for implementation and validation of a new PCR-based technology for mycoplasma testing of different products.
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Aurobac Therapeutics launched to fight antimicrobial resistance
Aurobac Therapeutics SAS - a €40m joint venture between Boehringer Ingelheim, Evotec and bioMérieux - has been launched to create the next generation of antimicrobials and diagnostics to fight antimicrobial resistance (AMR).
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Product hub: Environmental monitoring: a critical and challenging requirement
Read about bioMérieux's new system, 3P® ENTERPRISE - an end-to-end solution that fully digitalises and automates the EM process.
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The future of CMC for novel therapies
Novel and advanced therapies have come on in leaps and bounds over the past decade. Some cell and gene therapies have already reached the approvals stage, while others have now entered the later development stages. As a result, manufacturing process consistency, GMP standards and more must now meet more formal…
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Essential requirements for autologous cellular therapies
Edward Samuel, EVP Technical Operations at Achilles Therapeutics, explains why industrialised manufacturing and scale-up of autologous cellular immunotherapies will require fully closed systems and process automation.
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Bioprocessing/Bioproduction In-Depth Focus 2022
Download this in-depth focus to discover why closed systems and process automation are key for industrialised autologous cell therapy manufacturing and how CMC strategies for cell and gene therapies need to evolve.
