Helixmith US-based spinout has capitalised on its pDNA manufacturing experience with plans to launch a CDMO business
Photo as seen on Genopis website
At a corporate symposium held in San Diego, Helixmith and Genopis announced they will launch a contract manufacturing business for plasmid DNA production.
Key executives and leadership members of Helixmith and Genopis attended the symposium to declare the launch of CDMO service in Q2 2020 using Genopis' proprietary technology and the existing 500 L reactor.
Genopis was established in 2018 through a joint venture partnership by Helixmith (formerly ViroMed) and a private equity firm. The company is headquartered in San Diego, California
Moving ahead, the company will establish additional smaller-scale reactors (60-300 L, 6-30 L) with feasibility runs and start small-volume production service in the second half of the year.
Demand for plasmid DNA has risen steeply in recent years, driven by a boom in gene therapy development. pDNA is essential for the production of AAV (adeno-associated virus), lentivirus, and other viral vector platforms.
While many contract manufacturing organisations have experience producing DNA for early-stage exploratory studies, few companies have the GMP capabilities to meet FDA requirements. Genopis has decades of hands-on experience producing GMP pDNA for both early-stage and phase 3 clinical trials. Equipped with the right technologies and quality systems, Genopis' experience in and ability to efficiently execute GMP production for both clinical studies and future commercial purposes are key strengths.
Sunyoung Kim, who serves as CEO of both Helixmith and Genopis, said: "Our decision to launch the CDMO business is happening at a time when gene therapy is emerging as mainstream in the biopharmaceutical industry. In fact, with Genopis, Helixmith has become the only full platform company in the field of plasmid DNA medicine, with capabilities covering R&D, clinical study, and GMP production all together. New drug development takes a long time by nature, but we expect CDMO manufacturing to generate meaningful revenues in the near future."
As the demand for plasmid DNA surges beyond the production capacity of current CDMOs, some large companies are attempting M&As or scaling up existing facilities to expand production.
Alongside discussions with potential partners regarding strategic alliances and the use of its existing production capabilities, Genopis began upgrading its facilities in September of this year with the expectation of entering the CDMO space.
This is also a timely decision for Genopis, as the company will complete production of VM202 plasmid DNA in February 2020, a flagship product under clinical study by its parent company, Helixmith. Using Genopis' current 500 L reactor capability, Helixmith will secure VM202 pDNA required for its current clinical trials and regulatory needs for the next two years. Genopis will use the 500 L reactor for its CDMO service and the smaller scale production line once it is established in mid-2020.
Genopis has developed a shortlist of candidate clients and has been visited by large CMOs seeking strategic alliances and business opportunities.
Keith Hall, COO, said: "Genopis is a unique company, not only in the US but globally when it comes to plasmid DNA production. Our team of experts actually began cultivating this field 30 years ago."