Sphere Fluidics, a company developing single cell analysis systems underpinned by its patented picodroplet technology, today announced updates to 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 legally-mandated, quality requirements, the Company now provides a solution to increase efficiency and productivity of cell line characterization and selection within drug manufacture workflows.
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’s regulation for electronic documentation 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.
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 and analysis across an expanding range of emerging research areas, including precision genome editing, cell therapy research and cellular diagnostics.
The Cyto-Mine platform is now available ‘cGMP ready’, extending our range of customers to those operating in this tightly controlled, quality environment for the first time. With benefits in speed, cost and scalability, our picodroplet microfluidic technology has huge potential in drug manufacturing, and we’re excited to offer our updated product portfolio to new customers in this space.”
Richard Hammond, Chief Technical Officer, Sphere Fluidics