Bionova Scientific, a biologics contract development and manufacturing organisation (CDMO), has announced the opening of a 10,000 sqft plasmid DNA (pDNA) development and production facility in The Woodlands, Texas.
The Asahi Kasei subsidiary has built the new facility to design, develop and manufacture research-grade pDNA materials to support the cell and gene therapy field.
Darren Head, President and Chair of Bionova, explained that the expansion was initiated in response to persistent unmet need among the cell and gene therapy biopharma community.
“We chose The Woodlands because of its proximity to a growing number of CGT companies," said HEad.
Living products such as pDNA require very specific development conditions and contamination control measures.
A spokesperson from Bionova told Cleanroom Technology: “We utilise an isolator system that maintains a Grade A environment for all initial upstream open manipulations. Since our processes are fully closed and single-use, surrounding rooms have been classified as Grade D."
"Final filling is performed in a flexible system capable of handling both vials (for drug product) and bags (for drug substance). In addition, we operate a validated 24/7
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