MaxCyte to support Sana’s ex vivo cell therapy plans

Sana will use MaxCyte’s Flow Electroporation technology and ExPERT platform to drive its hypo-immune cell therapy pipeline.

The agreement, of which financial details have not been disclosed, sees MaxCyte sign a clinical and commercial license with Sana Biotechnology.

Sana will gain non-exclusive commercial and clinical rights to use MaxCyte’s Flow Electroporation technology and ExPERT platform and in return, MaxCyte is eligible to receive licensing fees and milestone payments.

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“MaxCyte’s ExPERT platform is based on the company’s proprietary Flow Electroporation,” MaxCyte CEO and Founder Doug Doerfler told BioProcess Insider.

“ExPERT uses its electroporation technology to apply an electric field to the che

“ExPERT uses its electroporation technology to apply an electric field to the cell membrane, temporarily increasing its permeability, to deliver molecules, such as genetic material and proteins. Without this technology, it generally would be difficult to cross the cell membrane. The ExPERT platform allows for complex and scalable cell engineering in a GMP format.”

According to Doerfler, its ExPERT platform is the leading electroporation technology “for complex and scalable cell engineering.”

He continued: “It is also supported by an FDA master file, an FDA submission of confidential detailed information about methods, processes, data and products. MaxCyte customers reference this file to support their own regulatory filings, reducing risks and challenges, which may speed up development timelines. Similar technical files are in place outside of the US.”

Since 1998, MaxCyte has approved 14 strategic platform licenses, which has allowed for more than 75 clinical programs. This includes Allogene who turned to MaxCyte’s technology to support its off-the-shelf chimeric antigen receptor (CAR)-T therapies in April 2020.

Why now?

“The MaxCyte portfolio mirrors the quickly evolving cell and gene-editing therapy market,” said Doerfler.

“Cell therapy has emerged as one of the fastest growing and most promising treatment modalities to address a host of human diseases. Over the past few years, the success of multiple FDA-approved cell therapies providing long-lasting amelioration of symptoms or even the cure of disease has catalyzed tremendous investment — leading to exponential growth in cell-based therapies being evaluated for therapeutic applications.”

The US Food and Drug Administration (FDA) predicted in January 2019 it would receive more than 200 regenerative cell and gene therapy INDs per year from 2020 and expects 10 to 2020 approvals per year by 2025.