CDMO’s Heidelberg facility will house the newly-completed manufacturing line.
AGC Biologics, a contract development and manufacturing organization (CDMO) that supports pre-clinical all the way through commercial fermentation projects, has completed the facility expansion of its new plasmid DNA (pDNA) and messenger RNA (mRNA) production line at its Heidelberg, Germany site. With this expansion and added production line, AGC Biologics can now offer more plasmid material in high-quality and good manufacturing practice (GMP) grades and extend the services for mRNA supply.
The new line features optimized personnel and material flow, new clean rooms for fermentation, chromatography, laminar flow and active pharmaceutical ingredient (API) filling, single-use bioreactor technology, and more warehouse space for managing incoming material. The expansion work also included adding independently operated production units for upstream and downstream pDNA processing, linearization, mRNA production, and a filling unit that help maintain compliance, quality and flexibility.
“ … 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,” says Dieter Kramer, site general manager, AGC Biologics Heidelberg.
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August 21st 2024Although it still has to undergo the preclinical and clinical trial process, the DNA vaccine—which could be created in as little as six weeks—does not require the cold chain storage that mRNA jabs often demand.