CDMO increases manufacturing capacities for plasmid DNA (pDNA) and messenger RNA (mRNA) projects at Plasmid Center of Excellence.
Today, we announced the completion of the facility expansion for our new plasmid DNA (pDNA) and messenger RNA (mRNA) production line at our Heidelberg, Germany site.
With this expansion and added production line, AGC Biologics can now offer more plasmid material in high-quality and GMP grades and extend the services for mRNA supply. The new production line utilizes state-of-the-art single-use equipment, creating the flexibility to produce different projects simultaneously, with shorter timelines and faster project turnover – allowing the CDMO to serve more developers in need of these materials.
The new line includes optimized personnel and material flow, new clean rooms for fermentation, chromatography, laminar flow and 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.
“The new addition to Heidelberg is a remarkable achievement for this site. We have integrated the latest single-use technology to support our unique plasmid DNA and messenger RNA offering,” said Dieter Kramer, Site General Manager, AGC Biologics Heidelberg. “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.”
AGC Biologics acquired the Heidelberg campus in 2016 and it has since become AGC Biologics’ European Center of Excellence for plasmid DNA, thanks to 40 years of historical expertise in microbial fermentation. With several decades of experience in microbial systems, our scientists support pre-clinical through commercial fermentation projects. AGC Biologics leveraged this knowledge to establish and grow its global pDNA and mRNA services at the site. Today, AGC Biologics Heidelberg offers full-scale support for microbial drug substances, plasmid materials, starting material for in-vitro transcription mRNA vaccines, and raw material for adeno-associated vectors and lentiviral vectors.
To learn more about the AGC Biologics Heidelberg facility, visit www.agcbio.com/facilities/heidelberg.
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