Is your clinical diagnostics contract manufacturer prepared to weather supply chain challenges?

1 Mar 2021

Supply chain security and transparency is a key part of the risk mitigation strategy of companies manufacturing clinical diagnostic assays. Covid-19-driven regional manufacturing shutdowns, surge demands, and logistics disruptions have placed significant pressure on clinical diagnostic supply chains, resulting in raw material shortages and delays. In this application note, explore some of the key factors to consider when choosing a contract manufacturing organization (CMO) partner to relieve manufacturing constraints and increase capacity during turbulent times.

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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.Consultancy ServicesLaboratory consultancy services are available for automated systems design, research and development, lab equipment procurement and lab equipment rental.Sample ManagementSample management systems include sample storage devices such as freezers and plate storers, sample environment enclosures and sample organization, retrieval and sorter systems. Useful system features include high-throughput, automation, robotic arms, automated liquid handling and associated database systems. Accessories in sample management include barcode scanners, heat sealers and tubes.ImmunologyImmunological techniques measure and characterize immune responses. Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.Clinical TrialsClinical Trials, an essential part of drug discovery process, assess the safety and effectiveness of a new medication or device in the pharmaceutical industry. Clinical Trials are a phased process (Phase 0, Phase I, Phase II, Phase III and Phase IV) which begins after initial preclinical testing.RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. In Vitro DiagnosticsIn vitro diagnostics (IVD) involve testing samples outside the body, typically in a laboratory, to diagnose diseases or conditions. IVD technologies include blood tests, molecular assays, and other bodily fluid tests, enabling accurate diagnosis and monitoring of diseases. These tests are essential for guiding treatment decisions in clinical settings. Browse our peer-reviewed product directory to find the best IVD solutions; compare products, check reviews, and get pricing directly from manufacturers.Molecular 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.ManufacturingManufacturing is the production of merchandise for use or sale using labor and machines, tools, chemical and biological processing, or formulation.Covid-19COVID-19, caused by the SARS-CoV-2 virus, has led to a global health crisis with profound impacts on societies and economies. Research into diagnostics, vaccines, treatments, and understanding viral mechanisms continues to evolve. The pandemic has accelerated innovations in healthcare and biopharmaceuticals, including novel vaccine platforms and rapid testing technologies. Browse our peer-reviewed product directory to find top COVID-19 testing kits, research tools, vaccines, and treatments, compare products, read reviews, and receive direct pricing from manufacturers.