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Maximize risk mitigation with custom cGMP oligos
28 Mar 2024Manufacturing oligonucleotides under cGMP maximizes risk mitigation by minimizing the probability of contamination, mix-ups, deviations, failures, and other errors, which in turn ensure that the oligo products meet the stringent requirements of molecular diagnostics, laboratory developed tests, and preclinical research. In this brochure, Merck highlights the benefits of custom oligos made under these quality and manufacturing systems such as controlled processes, extensive traceability, batch consistency, reproducible results, and scalability. All products are manufactured in compliance with US GMP standards, utilizing classified cleanrooms and maintaining ISO 13485 Quality Management System certification. Custom cGMP oligos are available with various specifications and modifications for applications such as PCR, qPCR, and next-generation sequencing.
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Custom cGMP Oligos
MerckIf you commercialize Molecular Diagnostics (MDx), create Laboratory Developed Tests (LDTs), or conduct preclinical research, then your final kit, assay, or modality must have an extraordinary level of quality to comply with strict regulatory or study standards. In the case of oligonucleotide raw materials available with custom specifications, the only option you should consider is Custom cGMP Oligos.
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OligonucleotidesOligonucleotides are small nucleic acid polymers, usually less than 20 bases in length. Oligonucleotides can be made via enzymatic cleavage or more commonly by chemical synthesis with polymerases. Their use includes FISH, southern blots, microarrays and as primers in PCR. High fidelity synthesis kits and detection systems are available for easy production and detection, respectively.PCR and Thermal CyclingPolymerase chain reaction (PCR) kits and thermal cyclers are used for the in vitro amplification of DNA permitting subsequent analysis and experimental procedures. Explore a range of high-quality polymerase, primers and nucleotides or simplify your workflow with a PCR mastermix. Find reverse transcription PCR (RT-PCR) and cDNA synthesis kits for RNA products and libraries. Quantitatively measure the amplification of DNA with real-time PCR (qPCR) and droplet digital PCR (ddPCR) kits and systems, and discover automated PCR setup solutions to increase throughput. Alternative DNA amplification methods also include recombinase polymerase amplification (RPA) kits. Find the best PCR kits and thermal cyclers and purification equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Data AnalysisData analysis hardware and software is available to make data processing straight-forward yet powerful. Data software can be used for math and stats, technical graphing and image analysis. In addition, software is available for specific data analysis of electrophoresis, densitometry, ELISA and DNA sequencing.Chem / BioinformaticsCheminformatics and bioinformatics are computational techniques used in chemistry and biology, respectively, for data acquisition, processing and storage. Cheminformatics focuses on compound information, whereas bioinformatics is mainly applied to analysis and modeling of genomics, genetic and sequencing information. Hardware and software is available for data acquisition, analysis, management and storage.Molecular Recognition SoftwareMolecular recognition software is widely used to analyze DNA, RNA, proteins and chemicals. The software can be useful for graphical viewing, comparative analyses, high-throughput screening, genomics, proteomics and phylogenetics. Molecular recognition software uses bioinformatics tools and analyses such as BLAST searches and generates structural predictions, 3D structures and sequencing information.Next Generation SequencingNext-generation sequencing (NGS), also known as whole-genome sequencing, high-throughput sequencing and massive parallel sequencing, produces and analyses thousands to millions of nucleotide sequences at once. Sequencing systems operate via varying technologies depending on the manufacturer, including sequencing by synthesis, ligation, pyrosequencing, ion semiconductor and single-molecule real-time sequencing. For NGS, library preparation is paramount to successful sequencing. In this section, explore a range of library preparation kits, from targeted, amplicon-based or hybridization-based kits including epigenomic, transcriptomic and genomic workflows to fragmentation kits. Find the best next-generation sequencing products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Laboratory ManagementLaboratory management involves overseeing the operations of a lab, ensuring compliance with safety regulations, optimizing workflows, and maintaining equipment. Efficient lab management is key to ensuring accurate results and minimizing downtime. Technologies like laboratory information management systems (LIMS) and automated lab equipment are helping labs streamline operations. Browse our peer-reviewed product directory to find the best laboratory management tools, compare products, read reviews, and get pricing directly from manufacturers.Quality ControlQuality control is needed in all production processes. Quality control is a monitoring procedure or set of procedures that are put in place to ensure that a manufactured product adheres to a defined set of quality criteria. qPCRQuantitative PCR (qPCR) is a molecular biology technique used to amplify and measure the amount of a specific DNA or RNA target. It plays a crucial role in gene expression analysis, pathogen detection, and quantifying DNA or RNA in various applications. Real-time PCR provides precise, quantitative results and is widely used in research, diagnostics, and clinical studies. Browse our peer-reviewed product directory to find the best qPCR solutions; compare products, check reviews, and get pricing directly from manufacturers.NGSMolecular DiagnosticsMolecular diagnostics use an individual’s genetic code and gene expression to diagnose and monitor diseases. The technique is used increasingly in the field of infectious diseases and oncology, as well as areas such as coagulation, HLA typing and pharmacogenomics. Molecular diagnostics plays a pivotal role in personalized medicine.