Sphere Fluidics, a company developing single cell analysis systems underpinned by its patented picodroplet technology, has revealed updates to the Cyto-Mine® platform. These updates ensure the Cyto-Mine® is compliant with current Good Manufacturing Practice (cGMP) regulations set forth by the US FDA. By meeting these legally mandated, quality standards, Sphere Fluidics now presents a solution aimed at increasing the efficiency and productivity of cell line characterisation and selection during drug manufacturing workflows.
Compliance to cGMP regulations assures the identity, strength, quality, and purity of drug products through the enforcement of sufficient control over manufacturing operations. The latest software updates for Cyto-Mine encompasses essential components such as 21 CFR Part 11, the FDA’s regulation for electronic documentation and electronic signatures, along with a comprehensive Installation Qualification / Operation Qualification (IQ/OQ) package. These additions facilitate swift equipment qualification processes. Aligning with cGMP regulations enables pharmaceutical manufacturers to seamlessly incorporate Cyto-Mine® into cell line development workflows, ensuring compatibility with subsequent regulatory requirements for biopharmaceutical approval.
Sphere Fluidics Cyto-Mine® is an automated platform which integrates single cell screening, sorting, dispensing, imaging, and clone verification. Leveraging patented microfluidic picodroplet technology, it presents an integrated system featuring an intuitive interface that can automatically screen up to 40 million cells within hours, compared with 10,000 typically achieved using multi-step manual techniques. This accelerated throughput has gained widespread recognition in various research areas, including antibody discovery, cell line development, cell engineering and synthetic biology. Additionally, the platform facilitates rapid, high-throughput single cell manipulation and analysis, expanding its application into emerging research areas such as precision genome editing, cell therapy research and cellular diagnostics.
In summary, the latest software updates support FDA 21 CFR Part 11 compliance and provide a full IQ/OQ package for pharmaceutical quality assurance while additional functionalities seamlessly extend Cyto-Mine® applications into manufacturing operations. To learn more contact Capella Science on (02) 9575 7512, sales@capellascience.com.au or Sphere Fluidics. For Research Use Only and not for use in diagnostic procedures.
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