US-based AGC Biologics has finished the expansion of its site in Heidelberg, Germany to include a production line for plasmid DNA (pDNA) and messenger RNA (mRNA).
The company is a biopharmaceutical contract development and manufacturing organisation (CDMO).
By adding the new expanded production line, AGC Biologics can now provide more plasmid material in high-quality and GMP grades and increase the range of mRNA supply services.
The expansion includes new advanced single-use equipment which gives the flexibility to work on multiple projects at once, with shorter lead times and quicker project turnover. This enables the company to supply more developers with pDNA and mRNA materials.
AGC Biologics revealed that the new line incorporates optimised personnel and flow of materials, new clean rooms for chromatography, fermentation, laminar flow, and API filling.
It also incorporates single-use bioreactor technology and additional warehouse space for managing incoming material.
Additionally, autonomously run production units for mRNA synthesis, linearisation, upstream and downstream pDNA processing, and a filling unit that supports project flexibility, quality, and compliance were included as part of the expansion work.
AGC Biologics Heidelberg site general manager Dieter Kramer said: “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.
“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 purchased the Heidelberg campus in 2016 and has since transformed it into the European Center of Excellence for plasmid DNA.
The site supports projects from pre-clinical to commercial phases using the company’s experience in microbial fermentation. Using this knowledge, the biopharmaceutical CDMO established and expanded its worldwide pDNA and mRNA services at the location.
Currently, AGC Heidelberg offers assistance for microbial drug substances, plasmid materials, raw materials for lentiviral and adeno-associated vectors, and starting material for in vitro transcription mRNA vaccines.
