The Cell and Gene Therapy Catapult (CGT Catapult), an independent innovation and technology organisation specialising in the advancement of the cell and gene therapy industry; Touchlight, a company pioneering enzymatic DNA production; and Complement Therapeutics, a preclinical stage biotechnology company developing novel therapeutics for complement-mediated diseases, have been awarded over £1 million in a grant from Innovate UK, as part of the ‘Innovative Technologies: Nucleic Acid Medicines Manufacture’ competition.
For potentially life-changing gene therapies to become more widely available to patients, there is a need to improve the manufacturing of these therapies, to increase yield and lower cost without compromising quality.
During this two-year project, Touchlight, the CGT Catapult and Complement Therapeutics will combine their expertise in gene therapy development and manufacturing to develop an innovative recombinant adeno-associated virus (rAAV) production process.
The project will use Touchlight’s enzyme-based DNA manufacturing platform to produce doggybone DNA (dbDNA™). dbDNA can be produced significantly faster than plasmid DNA which is more commonly used to manufacture rAAV gene therapies. The collaborators hope that, during the commercialisation of gene therapies, this approach will ultimately lower the cost of manufacturing AAV as well as have the additional benefit of reducing environmental burden, compared with manufacturing plasmid DNA.
The team will use dbDNA to produce rAAV which, in turn, will be used to manufacture Complement Therapeutics’ gene therapy candidates. CGT Catapult will optimise its rAAV manufacturing and analytical platform to support this manufacturing process.
The project will enable CGT Catapult to support other rAAV manufacturers around the UK to establish their own dbDNA-based manufacturing processes. By helping gene therapy developers improve their manufacturing, this has potential to make these therapies more affordable and accessible.
Karen Fallen, Chief Executive Officer of Touchlight, said: “We are excited to combine our dbDNA technology with those of Complement Therapeutics and CGT Catapult to develop an innovative solution to AAV production. dbDNA has the potential to improve the productivity and thus, the cost of AAV manufacture, while also eliminating bacterial impurities.”
Rafiq Hasan, Chief Executive Officer of Complement Therapeutics, said: “We are looking forward to this collaboration with colleagues from Touchlight and the CGT Catapult in exploring the potential of this innovative dbDNA technology in the manufacture of our AAV gene therapy candidates.”
Matthew Durdy, Chief Executive of the Cell and Gene Therapy Catapult, said: “Building on Touchlight’s pioneering dbDNA platform and Complement Therapeutics’ expertise in gene therapies, we hope to develop an innovative process that streamlines viral vector manufacturing and so helps to reduce the cost of advanced therapies. We look forward to working with Touchlight and Complement Therapeutics, both experts in advanced therapies, on this valuable project.”