Sphere Fluidics expands Cyto-Mine capabilities to meet cGMP requirements for drug manufacture workflows

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

Citations

Please use one of the following formats to cite this article in your essay, paper or report:

  • APA

    Sphere Fluidics. (2023, July 06). Sphere Fluidics expands Cyto-Mine capabilities to meet cGMP requirements for drug manufacture workflows. News-Medical. Retrieved on May 24, 2024 from https://www.news-medical.net/news/20230706/Sphere-Fluidics-expands-Cyto-Mine-capabilities-to-meet-cGMP-requirements-for-drug-manufacture-workflows.aspx.

  • MLA

    Sphere Fluidics. "Sphere Fluidics expands Cyto-Mine capabilities to meet cGMP requirements for drug manufacture workflows". News-Medical. 24 May 2024. <https://www.news-medical.net/news/20230706/Sphere-Fluidics-expands-Cyto-Mine-capabilities-to-meet-cGMP-requirements-for-drug-manufacture-workflows.aspx>.

  • Chicago

    Sphere Fluidics. "Sphere Fluidics expands Cyto-Mine capabilities to meet cGMP requirements for drug manufacture workflows". News-Medical. https://www.news-medical.net/news/20230706/Sphere-Fluidics-expands-Cyto-Mine-capabilities-to-meet-cGMP-requirements-for-drug-manufacture-workflows.aspx. (accessed May 24, 2024).

  • Harvard

    Sphere Fluidics. 2023. Sphere Fluidics expands Cyto-Mine capabilities to meet cGMP requirements for drug manufacture workflows. News-Medical, viewed 24 May 2024, https://www.news-medical.net/news/20230706/Sphere-Fluidics-expands-Cyto-Mine-capabilities-to-meet-cGMP-requirements-for-drug-manufacture-workflows.aspx.

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Unleashing the Power of Microfluidic Picodroplets