Genopis, plasmid DNA manufacturer in San Diego, to Launch GMP Contract Manufacturing Business
SAN DIEGO, Dec. 20, 2019 /PRNewswire/ — At a corporate symposium held in San Diego, Helixmith Co., Ltd. and Genopis, Inc. moved to 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 liter reactor. 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. Analyst estimates place the viral vector and plasmid DNA production market at around $290 million and expect the market to grow to $1.1 billion in 2023 with a CAGR of 25%.
While many contract manufacturing organizations 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.