AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced the completion of the facility expansion for its new plasmid DNA (pDNA) and messenger RNA (mRNA) production line at the CDMO’s 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 expand the services it offers for mRNA supply. The addition to the Heidelberg facility utilizes state-of-the-art single-use equipment, creating the flexibility to produce different projects simultaneously with shorter timelines and faster project turnover – allowing AGC Biologics to serve more developers in need of pDNA and mRNA 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 helps maintain compliance, quality and flexibility for each project.

“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 manufacturing and serve more developers in need of these materials worldwide.”

AGC Biologics acquired the Heidelberg campus in 2016 and it has since become the CDMO’s European Center of Excellence for plasmid DNA, thanks to 40 years of historical expertise in microbial fermentation, supporting projects from pre-clinical through commercial stages. 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.