Quality Systems

We maintain an ISO 9001:2015 compliant quality management system for the Design and Manufacture of Electroporation Instrumentation and Assemblies.

 

Compliance with ISO Standards has been continually maintained since it was first obtained in 2007.

Our cell-engineering delivery platform is clinically-proven, with growing use for the development of next-generation therapeutics.

 

SPECIFIC REAL-WORLD USE OF THE TECHNOLOGY INCLUDES:

An approved commercial immuno-therapy in Japan.

Referenced in multiple clinical trials, including several recently published/presented studies involving the expression of chimeric antigen receptors in autologous T cells.

Currently being used in more than 40 high-value cell therapy partnered programs covering cutting-edge fields of immuno-oncology, gene editing and regenerative medicine.

More than 15 programs have been licensed for clinical development and two programs for commercial use.

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