On May 9, 2023 Interius BioTherapeutics, a preclinical stage gene therapy company developing novel methods for in vivo cell-specific gene delivery, reported a manufacturing partnership with WuXi Advanced Therapies (WuXi ATU), a global Contract Testing, Development and Manufacturing Organization (CTDMO) (Press release, Interius BioTherapeutics, MAY 9, 2023, View Source [SID1234631249]). Interius has developed a process to manufacture INT-2104, an off the shelf lentivector product designed to create autologous chimeric antigen receptor (CAR) T cells directly in vivo in a patient’s body for the treatment of B cell malignancies. Through this partnership, Interius will leverage WuXi ATU’s CTDMO platform for Good Manufacturing Process (GMP) manufacturing of Phase I clinical product.

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"The Interius process leverages existing standard industry manufacturing processes and enables seamless transfer into cGMP settings for the manufacture of Phase I clinical material. Our process lends itself to scale up compatible with late-stage trials and commercial scale," said Tim Culp, Vice President of Research and Development of Interius. "We are delighted to work with WuXi ATU, a partner with integrated plasmid and vector manufacturing expertise."

Lentivirus vectors are typically used during the manufacturing of cell therapy products for allogeneic and autologous ex vivo CAR cell therapies. "The proprietary and novel nature of our platform necessitated the development of our own process at Interius. WuXi ATU has successfully scaled the process to 200L, and our partnership is an important step toward fulfilling the vision of Interius to enable broad patient access to CAR T therapies," said Dr. Phil Johnson, Chief Executive Officer of Interius.