Messenger RNA
Development & Manufacturing

FAQs

• What messenger RNA (mRNA) services does AGC Biologics offer?

  We offer comprehensive messenger RNA (mRNA) services, including process development and cGMP manufacturing for vaccines and therapeutics. Our capabilities support a wide range of scales and quality grades, ensuring a robust supply chain from a freedom to operate pDNA backbone and E. Coli strain with RNase-free and RNase-based processes, to final mRNA drug substance that includes LNP-based capabilities.

• What grades of mRNA do you manufacture?

  We manufacture mRNA in both R&D grade for pre-clinical use and cGMP grade for clinical and commercial applications.

• Do you supply the pDNA starting material for mRNA production?

  Yes, we have internal pDNA manufacturing and E. Coli strain for mRNA support at our facility in Heidelberg, allowing us to supply the linearized starting material required for your mRNA production. This in-house integration simplifies the supply chain and reduces timelines. We also offer freedom-to-operate and RNase-based and RNase-free processes​.

• What scales do you offer for mRNA manufacturing?

  Our flexible mRNA manufacturing platform offers single-use GMP manufacturing at 0.1 to 25 L IVT scale, Co- and post-capping for a flexible and IP-insensitive process, PolyA and polyA‑less workflows, integrated pDNA supply at all scales, and LNP microfluidics and mixing technology (other technologies also can be explored).

• Do you have an mRNA analytcs and QC process?

  Yes, we offer a full mRNA drub substance release testing panel, as well as method development and tech transfer support included. 

• Are your mRNA facilities compliant with global regulations?

  Yes, we operate in compliance with US FDA and EMA cGMP regulations to ensure your product meets global quality standards.