{"id":20283,"date":"2023-10-02T14:48:46","date_gmt":"2023-10-02T14:48:46","guid":{"rendered":"https:\/\/clinlabint.com\/?p=20283"},"modified":"2023-10-02T14:48:46","modified_gmt":"2023-10-02T14:48:46","slug":"sphere-fluidics-expands-cyto-mine-capabilities-to-meet-cgmp-requirements-for-drug-manufacture-workflows","status":"publish","type":"post","link":"https:\/\/clinlabint.com\/sphere-fluidics-expands-cyto-mine-capabilities-to-meet-cgmp-requirements-for-drug-manufacture-workflows\/","title":{"rendered":"Sphere Fluidics expands Cyto-Mine capabilities to meet cGMP requirements for drug manufacture workflows"},"content":{"rendered":"
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Sphere Fluidics expands Cyto-Mine capabilities to meet cGMP requirements for drug manufacture workflows<\/h1>\/ in E-News<\/a> <\/span><\/span><\/header>\n<\/div><\/section>
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Sphere Fluidics, a company developing single cell analysis systems underpinned by its patented picodroplet technology, has updated its flagship platform, Cyto-Mine, enabling it to be compliant with current Good Manufacturing Practice (cGMP) regulations enforced by the US FDA. By meeting these requirements, the company now provides a solution to increase efficiency and productivity of cell line characterization and selection within drug manufacture workflows.<\/h3>\n

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Adherence to cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring adequate control of manufacturing operations. The latest software updates for Cyto-Mine include: 21 CFR Part 11, the FDA\u2019s regulation for electronic documen-tation and electronic signatures, and a full Installation Qualification \/ Operation Qualification (IQ\/OQ) package, to support quick and easy equipment qualification. Compliance with cGMP regulations enables pharmaceutical manufacturers to integrate Cyto-Mine into cell line development workflows, ensuring compatibility with later regulatory needs for biopharmaceutical approval.<\/p>\n

Cyto-Mine is an automated platform which integrates single cell screening, sorting, dispensing, imaging, and clone verification. Underpinned by patented, microfluidic picodroplet technology, it provides an integrated system with an easy-to-use and intuitive interface that can automatically screen up to 40 million cells in a matter of hours, compared with 10,000 typically achieved using multi-step manual techniques. This accelerated throughput is already widely recognized across a variety of research areas, including antibody discovery, cell line development, cell engineering and synthetic biology. The platform also facilitates rapid, high-throughput single cell manipulation
\nand analysis across an expanding range of emerging research areas, including precision genome editing, cell therapy research and cellular diagnostics.<\/p>\n<\/div><\/section>
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