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New service offering is GMP compliant, with single-use fermentation capacity of up to 300 L
BioCina, a contract development and manufacturing organization (CDMO), is now expanding its CDMO service offering to include the manufacture of plasmid DNA (pDNA) in a new dedicated good manufacturing practice (GMP) suite. The suite is equipped with up to 300 L single-use fermentation capacity and downstream processing equipment. To complement GMP manufacturing, a broad range of analytical methods have been developed to support in-process, release and stability testing of pDNA products.
The company’s choice to expand its service offering into pDNA development and manufacturing was motivated by the global increase in demand for GMP-grade pDNA, fueled by the exponential growth in vaccines and therapies on the RNA platform, along with growth in the cell and gene therapy (CGT) markets.
"With its well-established expertise in the production of microbial derived biologics, BioCina is ideally suited to address the increasing global demand for GMP plasmid DNA,” says Rick Hancock, BioCina chairman. “Whether used as a raw material in the production of viral vectors or mRNA vaccines, or as the active ingredient for plasmid gene therapy or DNA vaccines, we look forward to partnering with innovators to assist in progressing many exciting therapies."