PI to manufacture Scinogy’s new cell processing system for cell therapy manufacture

8 November 2019

Planet Innovation is partnering with Melbourne-based start-up Scinogy to manufacture a revolutionary new cell processing system that is being commercialized by global biotechnology company Thermo Fisher Scientific.

The Gibco™ CTS™ Rotea™ Counterflow Centrifugation System has the potential to transform the cell therapy industry by greatly reducing the time and cost of manufacturing small batch cell therapies for patients with a wide range of diseases, including many cancers.

Cell and gene therapy development is typically a manual process, making it difficult to cost-effectively scale and commercialize. Rotea addresses this problem by being a flexible, closed and automated system that automates many of the commonly used processes such as cell separation, washing and concentration.

Importantly, Rotea has the flexibility to seamlessly scale from the research phase to the commercial manufacture of cell therapies.

David James, CEO of Scinogy, said the benchtop instrument addressed a gap in the market for small-scale manufacture of autologous cell therapies (where treatments are created using the patient’s own cells) and allogeneic therapies (where treatments are created using donor cells).

“Rotea can deliver a smaller volume of product at a higher concentration, than competing instruments with high recovery and viability. This is particularly important for autologous therapies where samples from sick patients are often limited,” David said.

Scinogy engaged PI to develop Rotea’s graphical user interface (GUI), and to manufacture the completed instrument and associated consumable in our ISO 13485-certified manufacturing facilityand recently established ISO 7-compliant cleanroom in Melbourne. David said PI’s willingness to work flexibly was one of the key reasons Scinogy chose to partner with us.

“PI offers a lot of commercial flexibility, there’s not one model that has to be applied to every project, and that has been really important to us,” David said. “The caliber of the team has been first class, from software to manufacturing. PI has also been able to deliver at the speed that we need, which has been very important as time to market is crucial.”

Colin Potter, GM Manufacturing, said the PI and Scinogy teams had been working very closely to get the Rotea and associated single-use kit into production.

“Rotea is a new, specialist product, that requires specialist attention. Our product managers have been working very closely with the team at Scinogy to ensure a smooth transfer to manufacture for the instrument and the consumable, and to put in place the processes to allow us to scale up production as demand grows.”

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