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Methods and Equipment for Quality Control of Radiopharmaceuticals
Published in Michael Ljungberg, Handbook of Nuclear Medicine and Molecular Imaging for Physicists, 2022
Rolf Zijlma, Danique Giesen, Yvette Kruiter, Philip H. Elsinga, Gert Luurtsema
Quality control equipment can be purchased from various vendors and be installed independently of each other. There is an increasing trend to link QC-equipment into one Laboratory Information Management System (LIMS). The advantage is that the analytical data from the different types of equipment are combined in one software system that facilitates the overall judgement of the combined data and release of the radiopharmaceutical for clinical use. Some vendors even combine the different equipment to reduce the overall laboratory space required (Figure 6.1).
Companion Diagnostic (CDx) Tests in Clinical Laboratory Improvement Amendments (CLIA)-Certified Laboratories
Published in Il-Jin Kim, Companion Diagnostics (CDx) in Precision Medicine, 2019
The following is an example of the NGS assay procedure (somatic mutation detection analyzing cancer tissues samples) done in a CLIA laboratory (Fig. 2.1).6 Specific details or procedures may be different from other CLIA laboratory tests. However, the overall structure of genetic tests should be similar to the process shown in Fig. 2.1. All procedures should be clearly written as Standard Operating Procedures (SOPs). A laboratory information management system (LIMS) helps to manage and control samples and data. We have developed a mobile application (app) named Mobile Genome Expression (MGE) for controlling all of the genetic procedures, from sample preparation and bioinformatics analysis to reporting the result.26 This kind of mobile app-based genetic controller is expected to be used for efficient management of a CLIA laboratory.
Transfusion medicine
Published in Ian Greaves, Military Medicine in Iraq and Afghanistan, 2018
The most significant impact of the changes in clinical policy and workload was the demand for blood components. An important early development was the introduction of a Laboratory Information Management System (LIMS) in 2009. LIMS, together with bar code readers, transformed the speed and accuracy with which staff could issue large amounts of blood components. The blood issued to theatre and BST activity from 2006 to 2014 is shown in Figures 14.3 and 14.4.
The Effects of Vitamin E, Silymarin and Carnitine on the Metabolic Abnormalities Associated with Nonalcoholic Liver Disease
Published in Journal of Dietary Supplements, 2022
John E. Poulos, Peter T. Kalogerinis, Valentin Milanov, Constantine T. Kalogerinis, Emanuel J. Poulos
Authentication and verification of the content and stability of VSC involved Fourier Transform Infrared Spectroscopy, Fourier transform near-infrared spectroscopy, High-performance thin-layer chromatography, and compendial monograph testing for positive identification of all materials. Ultra-Performance Convergence chromatography was utilized for the analysis of vitamin E. All operations and processes in the manufacturing of VSC were conducted in accordance with current Good Manufacturing Practices (cGMPs) as required by the United State Food and Drug Administration under 21 CFR, Part 111 (Dietary Supplements) and Part 117 (Food Safety). Physical testing including USP disintegration, dissolution, physical appearance, and identification. Also, the purity of all finished products was confirmed via testing for heavy metals (inductively coupled plasma mass spectrometry), pesticides (liquid chromatography-mass spectrometry), and residual solvents, as well as microbiological testing. The testing of finished VSC was conducted in comparison to established finished product specifications contained within a controlled database that stipulates the label claims and acceptable ranges for each ingredient. Certificates of Analysis (COA) were issued for each batch of finished product via a state-of-the-art laboratory information system (LIMS) listing the applicable laboratory testing that was conducted and the specifications used.
Pharmacokinetics and metabolic disposition of a potent and selective kynurenine monooxygenase inhibitor, CHDI-340246, in laboratory animals
Published in Xenobiotica, 2021
Vinod Khetarpal, Todd Herbst, Diana Shefchek, Steven Ash, Michael Fitzsimmons, Mark Gohdes, Ignacio Munoz-Sanjuan, Celia Dominguez
The liquid chromatography was performed on a Shimadzu HPLC system (Shimadzu Corporation, Columbia, MD) using Leap CTC PAL autosampler. The chromatography was performed on a Waters XBridge C18 (2.0 × 50 mm, 2.5 µm particle size) column, using a mobile phase flowing at a rate of 0.24 mL/min comprised of solvent A (10 mM ammonium bicarbonate in water with 0.04% ammonium hydroxide) and solvent B (methanol with 0.1% ammonium hydroxide) with gradient of 0% solvent B at 0.4 min to 25% at 3.8 min. Mass spectrometer detection was performed on an API 4000 (Applied Systems, Foster City, CA) with multiple reaction monitoring (MRM) for CHDI-340246 and its analogue, CHDI-313259, at m/z 291.1 →114.1 and 235.1 →161.9. The quantification was performed via peak area ratio. Data acquisition and processing were accomplished using Watson LIMS.
Uppsala Biobank—the development of a biobank organization in a local, regional, and national setting
Published in Upsala Journal of Medical Sciences, 2019
Health care integrated biobanking has now spread throughout the Uppsala–Örebro health care region. The region includes seven county councils (Uppsala, Örebro, Dalarna, Gävleborg, Värmland, Västmanland, and Sörmland). Apart from Uppsala, also Örebro, Gävleborg, and Värmland have started HIB in 2014, and Dalarna as well as Västmanland will start shortly. Sörmland is planning to start in 2019. The Uppsala–Örebro region collaborates within the regional biobank council. In order to work efficiently the decision was made to share a common regional Biobank LIMS. The regional Biobank LIMS is hosted and developed by Uppsala Biobank. Uppsala Biobank, with the support of the principals, is investing in an automated solution for long-term low-temperature storage (-80 °C). Uppsala Biobank will also support the region with automation for storage and withdrawals if needed, e.g. the county of Gävleborg has decided to send their samples to Uppsala for storage and withdrawals.