BioCina and GenomeFrontier Therapeutics have partnered to develop virus-free chimeric antigen receptor T cell products (CAR-T) to treat cancer.
Contract development and manufacturing organization (CDMO), BioCina aims to support GenomeFrontier with development and GMP manufacturing for minicircle DNA (mcDNA) and plasmid DNA.
Additionally, the Australian firm GenomeFrontier will provide access to their proprietary virus-free cell and gene engineering platforms, and Quantum Engine, which is a cell-engineering system for the Phase I clinical trial.
c/o BioCina
“BioCina and GenomeFrontier have commenced a long-term partnership, wherein we will be the manufacturer of all mcDNA and plasmid DNA required to produce CAR-T by GenomeFrontier for future clinical trials and commercial use,” CEO for BioCina, Mark Womack told BioProcess Insider. “BioCina’s batch manufacturing operations will occur in Q1 and Q2 2024.”
Minicircle DNA is a smaller and as per the firm safer version of non-viral DNA vectors that result from a recombinant process designed to excise prokaryotic sequences from plasmid DNA.
“BioCina will tech transfer and implement a novel mcDNA manufacturing process using its existing large-scale GMP plasmid manufacturing equipment train,” said Jan Bekker, director of strategy, science, and innovation for BioCina.
“This will be the first time this new mcDNA technology is employed in a GMP manufacturing setting anywhere. The mcDNA manufacturing process will be scaled over 20x by BioCina’s expert process engineers, to enable the manufacture of large-scale engineering and GMP batches. The large-scale manufacturing process will be designed to deliver a high yield of both the mcDNA and plasmid DNA vectors which will be used to manufacture CAR-T cell therapies for the treatment of B-cell lymphomas.”
This new method can overcome the existing challenges in virus-based transfer technologies including safety risks, limited payload capacity and prohibitive manufacturing cost, the firm said. Moreover, mcDNA has great potential in overcoming these hurdles as non-viral DNA-based vectors replacing the traditional viral vectors in the biomanufacturing of cell therapies.
However, for the method to be effective, it needs to simultaneously achieve high gene delivery to cells and effectively integrate multiple genes into the genome.
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