AGC Biologics Successfully Expands its pDNA and mRNA Production Lines in Heidelberg
Friday, October 13, 2023
AGC Biologics, a prominent global Contract Development and Manufacturing Organization (CDMO) specializing in the biopharmaceutical industry, is pleased to announce the successful expansion of its facility in Heidelberg, Germany. This expansion includes the addition of a new production line dedicated to plasmid DNA (pDNA) and messenger RNA (mRNA) production.
This development marks a significant milestone for AGC Biologics, as it now has the capacity to provide high-quality and Good Manufacturing Practice (GMP) grade plasmid materials and broaden its services related to mRNA supply. The newly added production line is equipped with state-of-the-art single-use technology, allowing for concurrent production of various projects with reduced timelines and faster project turnover. This enhancement empowers AGC Biologics to cater to a larger clientele in need of pDNA and mRNA materials.
The upgraded facility features an optimized layout for personnel and material flow, incorporating new clean rooms for fermentation, chromatography, laminar flow, and active pharmaceutical ingredient (API) filling. It also includes single-use bioreactor technology and expanded warehouse space for efficient management of incoming materials. Furthermore, the expansion includes independently operated production units for upstream and downstream pDNA processing, linearization, mRNA production, and a filling unit that ensures compliance, quality, and adaptability for each project.
Dieter Kramer, Site General Manager of AGC Biologics Heidelberg, expressed his satisfaction with the expansion, stating, "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 acquired the Heidelberg campus in 2016 and has since transformed it into the CDMO's European Center of Excellence for plasmid DNA. With a rich history of 40 years in microbial fermentation, the site has been instrumental in supporting projects from pre-clinical stages to commercial production. Leveraging this expertise, AGC Biologics has expanded its global services for pDNA and mRNA at the Heidelberg site. Today, AGC Biologics Heidelberg provides comprehensive support for microbial drug substances, plasmid materials, starting materials for in vitro transcription mRNA vaccines, and raw materials for adeno-associated vectors and lentiviral vectors.
Source: businesswire.com
