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news.AGC Biologics has completed the facility expansion for its new plasmid DNA (pDNA) and messenger RNA (mRNA) production line at Heidelberg, Germany.
The newly added line comprises new clean rooms for chromatography, fermentation, laminar flow and API filling. Credit: AGC Biologics.
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With this expansion and added production line, the company can now offer more plasmid material in quality and GMP grades as well as extend the mRNA supply services.
The new line comprises new clean rooms for fermentation, chromatography, laminar flow and API filling, single-use bioreactor technology, additional warehouse space for incoming material management, and optimised personnel and material flow.
Besides, the expansion included linearisation, independently operated production units for upstream and downstream pDNA processing, mRNA production and a filling unit for maintaining quality, compliance and flexibility.
AGC Biologics Heidelberg site general manager Dieter Kramer said: “We have integrated the latest single-use technology to support our unique plasmid DNA and messenger RNA offering.
“This expansion complements our comprehensive capabilities and allows us to offer scalability for pDNA and mRNA manufacturing and serve more developers in need of these materials worldwide.”
In 2016, AGC Biologics purchased the Heidelberg campus that provides full-scale support for starting material for in-vitro transcription mRNA vaccines as well as raw material for adeno-associated vectors and lentiviral vectors.
The campus has become the company’s European Center of Excellence for plasmid DNA.
