Your Global Drug Development Organization For Analytical Laboratory Testing and Clinical Research.
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What’s the difference between High Performance Liquid Chromatography (HPLC) and Ion Chromatography (IC)? What are the capabilities and limitations of each technique? Knowing these differences can actually make a huge difference.
Whitepaper: A study of the peristaltic life and pumping performance of three TPE tubing products to assess their suitability for continuous bioprocessing
Drug manufacturers are increasingly adopting continuous bioprocessing to manufacture biologics as efficiently as possible. This is being driven by a need to reduce production costs and prices of pharmaceutical products. Furthermore, the FDA has stated its support for the implementation of continuous bioprocessing. A key consequence of continuous bioprocessing is…
Most laboratories today now have some form of LIMS to help manage their workflow. There are many types of LIMS, ranging in complexity from spreadsheets to intelligent programs that manage nearly every lab function.
Data integrity requires data to be complete, consistent, and accurate throughout their complete lifecycle, providing full transparency and traceability. Industry guidelines such as ALCOA and ALCOA+ describe these requirements, which are used by the FDA, WHO, PIC/S and GAMP. All major Metrohm software products make compliance with the ALCOA and…
Liquid chromatography mass spectrometry (LC-MS) is a highly accurate and sensitive platform used in biopharmaceutical research and development.
The characterization of novel therapeutics involves many chemical processes.
LIMS requires a high degree of customization to meet QC Microbiology requirements. This means LIMS implementations often lock users into a functionality set that can’t accommodate technology advancements and regulatory changes without considerable investments, time, effort and money.
This application brief presents a framework for how to establish acceptance criteria limits using TOC to comply with FDA best practice guidance for the life cycle approach to cleaning validation.
Confirming product authenticity, combating counterfeiting and preventing product diversion are key for compliance within the global supply chain. This whitepaper focuses on pharmaceutical serialisation and solutions to combat producers of counterfeit products.
Positron emission tomography (PET) is a popular nuclear imaging technique used to gain information about specific metabolic functions.
Would a LIMS or SAP better meet the needs of your company? That is the eternal debate for organizations who are thinking about upgrading their laboratory tracking software to a professional management system - analogous to the Mac vs PC conundrum on an industrial scale.
The purpose of this Position Paper is to consider the scientific basis for accelerating extractables and/or leachables studies via the proper combination of contact temperature and duration (time). Considering this scientific basis, recommendations concerning proper acceleration strategies are provided.
The purpose of this Technical Communication is to establish how General Chemistry Data obtained in controlled extraction studies, such as pH, UV absorbance and total organic carbon (TOC), is reported, used and discussed as part of a rigorous extractables assessment.
The MiniCapt Mobile Microbial Air Sampler allows the user to perform viable air sampling in cleanroom environments for classification and monitoring purposes.