Policy & Regulation
Made Scientific and Basilard BioTech partner on advancing ex vivo gene delivery for T cell and iPSC therapies
16 September 2025 -

Made Scientific, a US-based cell therapy contract development and manufacturing organisation (CDMO), and Basilard BioTech, a Southern California biotechnology company involved in novel delivery technologies for cell and gene therapy, announced on Monday a strategic collaboration to accelerate the development and translation of Basilard BioTech's nanomechanical gene delivery platform, Celletto.

Celletto is a disruptive nanomechanical gene delivery technology that is designed to address long-standing limitations of both viral vectors and conventional non-viral methods. By creating a controlled, transient disruption to the cell membrane using nanoneedles to directly transport nucleic acids (or any construct) into the nucleus of any cell type each time, Celletto is claimed to enable exceptionally high transfection efficiency while preserving cell viability and function, unlike viral systems that are costly, complex, and carry insertional mutagenesis risks, or chemical/electroporation approaches that compromise viability,

According to Made Scientific, Celletto provides: superior cell viability - maintains the functional integrity of sensitive cell types, including T cells and induced pluripotent stem cells (iPSCs), enabling higher recovery rates and robust expansion; high gene transfer efficiency - achieves reliable and reproducible delivery of genetic payloads across diverse constructs, including large plasmids and gene-editing components; scalability and flexibility - engineered on silicon wafers as a modular platform adaptable for both small-scale research use and GMP-compliant large-scale manufacturing, offering a clear path from bench to clinic; and reduced cost and manufacturing complexity - by eliminating dependence on viral vectors, Celletto can significantly shorten production timelines and reduce costs, helping to make advanced therapies more accessible.

Under the agreement, Basilard BioTech will leverage Made Scientific's Center of Excellence for Process and Analytical Development and GMP manufacturing facility in Princeton, NJ, to validate and scale the Celletto platform across T cell, iPSC processes, and other cell substrates in the future.

The companies say that on-site installation, training, and execution of joint studies is underway, with initial data readouts expected by the end of Q3 2025, and publication of results and presentation at upcoming industry conferences.

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