ViroMed said Wednesday it acquired a DNA production facility in San Diego, Calif., as it is wrapping up a phase 3 trials for its plasmid DNA-based gene therapy drug, VM202.
The facility, previously used to create DNA for various clinical trials, holds a 500-liter production tank used to develop the genetic codes. It also has the hardware infrastructure and soft assets that allow for commercial production, the company said.
Also, the facility has a cell culture room and a QC laboratory, which can provide the necessary infrastructure for advanced biopharmaceutical research and manufacturing.
The Korean biopharmaceutical firm is on the edge of finishing its phase 3 trial for VM202. VM202 is a plasmid DNA-based gene therapy drug containing hepatocyte growth factor (HGF) genes.
ViroMed aims to enter good manufacturing practice (GMP)-based production in the first half of next year by simulating a pilot trial run in the second half of this year, it said.
Since nearing completion of its clinical trials, the firm said the problem of production had been the biggest concern. There are only a small number of contract manufacturing organizations (CMO) that can produce plasmid DNAs, which had not been commercialized.
“Most CMOs unilaterally determined the production schedule and price in many cases, leading to trial-and-error on ViroMed’s part,” the company said.
The acquisition of the San Diego plant has solved the problem, according to the company.
“We are very pleased that the problem of production – which was the biggest variable – has been solved through the acquisition of the production facility,” ViroMed CEO Kim Sun-young said.
ViroMed has become a world-leading biopharmaceutical firm in DNA gene therapy, capable of covering all aspects of new drug development from R&D to production facilities while holding QA / QC capabilities, he added.
<© Korea Biomedical Review, All rights reserved.>