Whitepapers
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WhitepaperStrategies for endotoxin testing of RNA-LNP
Overcome matrix interferences in RNA–LNP endotoxin testing with LAL-based methods & recombinant factor C assays. Learn more in this whitepaper.
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WhitepaperNSF’s quality management maturity (QMM) assessment model
NSF’s quality management maturity (QMM) assessment model: future-proofing quality and supporting supply chain robustness
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WhitepaperRegulatory Authority Inspection Comparison
A guide on what to expect during a regulatory inspection and the differences in the approach taken by three of the main regulatory authorities and PIC/S.
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WhitepaperApplication note: The need for rapid methods in the compounding pharmaceutical industry
This application note explores rapid microbial methods and balancing patient care, quality products, and safe shelf lives for unique formulations.
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WhitepaperWhitepaper: Optimise organisational culture & quality maturity
Whitepaper - Optimising organisational culture and quality maturity is crucial in promoting consistent, reliable business processes and to minimise supply disruptions.
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WhitepaperDelivering market success for concept to patient
Whitepaper - Delivering Market Success for Pharma Partners from Concept to Patient
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WhitepaperScience of scale for spray-dried intermediates
Speed to market is a critical aspect of developing new pharmaceutical products, and scale-up – or scale-down – can play a key part in that process.
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WhitepaperWhitepaper: USP <645> Water Conductivity Regulations
This whitepaper looks at benefits of measuring conductivity on-line, and calibration and temperature compensation criteria for USP compliance.
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WhitepaperSynthesis and Route Design to Tackle API Complexity
These longer synthetic pathways present challenges for process chemists hoping to achieve an efficient API manufacturing process.
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WhitepaperApplication note: Highly efficient method development using LC-MS for automated peak tracking
Peak tracking in liquid chromatography (LC) method development can be challenging due to retention variations and co-elution. LabSolutions MD software with LCMS-2050 SQ-MS simplifies peak identification and automates method and sequence creation, enabling efficient development of reliable separation methods.
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WhitepaperAdvertorial: 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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WhitepaperApplication 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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WhitepaperApplication 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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WhitepaperCase study: Data-driven water system maintenance
This case study looks at how an online microbial analyzer provides real-time bioburden monitoring for rapid response to adverse water system events.
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WhitepaperCase Study: Franz Ziel’s utilisation of Enzyme Indicators using Fractional Kill Time method
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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Whitepaper
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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WhitepaperWhitepaper: Redefining Clinical Trial Decision-Making: Leveraging NLP for extracting insights from unstructured data
Leveraging next-gen technologies such as NLP in data ingestion and extraction, can enable systems to seamlessly extract and analyse such free texts.
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Whitepaper
Solution brief: Environmental monitoring software
Monitoring microbial contamination levels at various stages requires focused, independent software with extended controls over microbial management. Digital monitoring of contaminants and their sources helps understand microbial behavior and trends. Thus, a reinforced, data- driven environmental monitoring mechanism is the key to maintaining controlled lab spaces for microbial trend analysis. ...
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WhitepaperWhitepaper: Complete Automation System for Endotoxin Testing
Automating a Laboratory’s BET workstream using Lonza’s PyroTec® PRO Robotic Solution, WinKQCL® Software, and MODA® Software.
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WhitepaperProduct hub: High fidelity process control with Bruker’s Fourier PAT
Bringing a wealth of structural information and direct quantification to the lab or plant, the Fourier PAT benchtop NMR reduces tedious calibrations and increases (bio)process understanding and control, hence further reducing risks and cost.