Comprehensive GMP Manufacturing Of mRNA-LNP Drug Products: Sequence-To-Vial

The manufacture and release of mRNA therapeutics and vaccines is a complex and challenging process requiring a high degree of expertise, capabilities, and experience. The development and manufacturing of final drug product involves several stages that include production of cell banks, linear DNA, and mRNA drug substance, with lipid nanoparticle (LNP) formulation/encapsulation and analytical testing at all steps, through aseptic fill/finish.

Over the last 25 years, Aldevron has demonstrated tremendous growth and a proven track record when it comes to GMP manufacturing for biotherapeutics, ensuring that high quality products are being delivered to patients in need. Aldevron has been producing GMP batches of mRNA since 2018 and has since expanded to support Protein Replacement, Cell Therapy, Gene Therapy, and Infectious Disease.

Aldevron’s newly expanded sequence-to-vial mRNA ecosystem provides a streamlined service in the development, production, and release of both mRNA drug substance and drug product, which includes LNP encapsulation and aseptic fill-finish capabilities. Learn how delivering a comprehensive CMC package under a single manufacturer can help to minimize the logistical complexity of multiple vendors that leads to major risks for RNA program success.