Under the partnership, Charles River will use its contract development and manufacturing organisation expertise in HQ plasmid DNA production to manufacture candidates for Phase 1/2 clinical trials for INAD
INADcure enter into gene therapy manufacturing collaboration. (Credit: Sangharsh Lohakare on Unsplash)
Charles River Laboratories and non-profit organisation INADcure Foundation have announced a partnership for manufacturing plasmid deoxyribonucleic acid (DNA).
INADcure Foundation is engaged in supporting the development of therapies for infantile neuroaxonal dystrophy (INAD) and other forms of PLA2G6-related neurodegeneration (PLAN).
Under the partnership, Charles River will use its contract development and manufacturing organisation (CDMO) expertise in High Quality (HQ) plasmid DNA production to manufacture its candidate for Phase 1/2 clinical trials for infantile neuroaxonal dystrophy.
INADcure Foundation, established in 2016, aims to accelerate research and drive drug discovery.
Currently, the organisation is working on the development of a gene therapy treatment for children affected by INAD, a rare neurodegenerative disease.
INADcure founder and executive director Leena Panwala said: “Our collaboration with Charles River brings us closer to accomplishing our goal of delivering breakthrough treatments for INAD.
“We are excited to begin HQ plasmid DNA manufacturing to further develop our treatment with their experienced team. Their invaluable expertise will undoubtedly contribute to the advancement of our gene therapy program.”
The plasmid DNA production of Charles River, particularly HQ plasmid, is said to combine the main features of good manufacturing practice (GMP) with fast turnaround times to expedite the timeline to the clinic.
Recently, the CDMO opened its advanced HQ plasmid manufacturing centre of excellence to meet the supply shortages and increasing needs of the cell and gene therapy field.
In 2021, Charles River acquired Vigene Biosciences, Cobra Biologics, and Cognate BioServices to expand its cell and gene therapy portfolio.
The company now has CDMO capabilities in plasmid DNA, viral vector, and cellular therapy production for clinical through to commercial supply.
Charles River biologics solutions corporate senior vice president Kerstin Dolph said: “The opportunity to work with INADcure is exactly why we do the work we do. Their work is incredibly important to patients with this ultra-rare disorder.
“We are excited for the INADcure team to achieve this next stage of treatment development.”
In February this year, the firm inked a plasmid DNA CDMO collaboration with Purespring Therapeutics to develop the first gene therapy platform for kidney diseases.