HILTON HEAD ISLAND, South Carolina, March 4, 2019: Bruker is expanding its pharma and industrial NMR, EPR and related software solutions at PANIC 2019, the ‘Practical Applications of NMR in Industry Conference’ (www.panicnmr.com). The new productivity and compliance tools include:
New Compliance Tools for Regulated Markets: Adherence to compliance with GxP is mandatory in regulated environments of the pharmaceutical and CRO/CMO industries. Bruker’s new NMR qualification solutions and GxP readiness kit includes software, certificates and manuals for Installation Qualification (IQ), Operation Qualification (OQ), Computer System Validation (CSV), and Performance Qualification (PQ). IQ and OQ protocols can be performed by qualified Bruker engineers working with customers during NMR installations or service visits.
Quantitative Performance Qualification (qPQ) for Quantitative NMR (qNMR) Applications: A collaboration between Bruker and MilliporeSigma has led to the development of certified reference material (CRM) tailored to qNMR. A novel, two-component mixture that is manufactured in the ISO/IEC 17025 and ISO 17034 accreditated workflow at the MilliporeSigma site in Buchs, Switzerland, and it is the basis of the new qPQ test. This qPQ is now incorporated within the Bruker AssureSST™ software, allowing automated PQ tailored to qNMR.
Markus Obkircher, Director of Reference Materials R&D at MilliporeSigma, commented: “This product could only be realized within such a short timeframe by a transparent and collaborative innovation approach and by bringing together core competences of Bruker and MilliporeSigma in the field of quantitative NMR, reference materials development and metrology. The application of the qPQ Certified Reference Material in Bruker’s AssureSST platform will enable scientists to accurately acquire and process NMR data based on a time-saving, robust, standardized and validated workflow.”
Merck KGaA Darmstadt, Germany, holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials.
NMR, Mass Spec and EPR Impurity Profiling and Control: Regulatory expectations driven by patient safety considerations often require identification and structure elucidation of impurities at levels greater than 0.1% in the active pharmaceutical ingredient (API). Mass spectrometry (MS) and NMR are complementary tools for impurity identification and molecular structure information. In addition, EPR can measure small amounts of free radicals and transition metals. EPR is also important in accelerated-degradation (e.g. oxidation) studies and shelf-life determination. Bruker’s EMXnano™ benchtop spectrometers can bring affordable, routine EPR to pharmaceutical and food process development and QC.
Autocalibrate for Intelligent NMR Spectrometer: AutoCalibrate™ is an imbedded new tool in Bruker’s automation software IconNMR that determines the optimal settings for key NMR parameters, logs results and monitors changes. AutoCalibrate is key to maintaining well-tuned NMR spectrometers, tracking changes and monitoring the long-term performance health of the entire system.
Bruker and Mestrelab Expand Software Solutions Portfolio for Pharmaceutical & Industrial NMR: The laboratory of tomorrow requires the integration of multiple technology platforms. The previously announced strategic collaboration of Mestrelab and Bruker is expected to provide a simple, instrument-to-result automation environment that allows end users to build automated solutions tailored to their workflow. An example of this is the integration of Bruker’s Fragment-Based Screening (FBS) solution with Mestrelab’s MScreen software, which provides drug discovery groups with an integrated experience from data acquisition and data analysis to the identification of hits in FBS-by-NMR campaigns. This integration will be showcased with demonstrations of a beta version at Mestrelab.
Bruker is enabling scientists to make breakthrough discoveries and develop new applications that improve the quality of human life. Bruker's high-performance scientific instruments and high-value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular and microscopic levels. In close cooperation with our customers, Bruker is enabling innovation, improved productivity and customer success in life science molecular research, in applied and pharma applications, in microscopy and nanoanalysis, and in industrial applications, as well as in cell biology, preclinical imaging, clinical phenomics and proteomics research and clinical microbiology.