mRNA Vaccine Manufacturing Services

An integrated solution for mRNA vaccine manufacturing

mRNA platforms are reinventing how prophylactic and disease-targeted vaccines are delivered. Arranta Bio is helping advance the industry by combining the entire mRNA value chain under one roof. We provide a complete, end-to-end solution for developing and manufacturing plasmid, mRNA, colloidal delivery systems including lipid nanoparticles (LNP) and the injectable sterile drug product, enabling our partners to gain speed-to-market advantage with next-generation mRNA products.

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Services

Plasmid starting material and linearization
In-vitro transcription (IVT)
mRNA purification
Lipid Nanoparticles (LNPs)
Sterile injectable fill/finish
Analytical development, qualification and validation
cGMP cell banking
cGMP clinical and commercial manufacturing
QC release and stability testing
Process characterization
CMC regulatory services
Custom process establishment, manufacturing and strategic partnerships

Capabilities

End-to-end, integrated mRNA production from starting materials to sterile drug product
Plasmid linearization and other mRNA starting materials
mRNA Drug Substance up to 100 g per batch in Grade C suites
Lipid Nanoparticles (LNP) encapsulation of mRNA with a choice of mixing technology platform up to 50 g
Aseptic filling using state-of-the-art, integrated, gloveless robotic isolator with advanced automation provides best-in-class sterility assurance for injectable batches up to 20,000 units

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mRNA Process Transfer, Development and Characterization

Arranta Bio has dedicated laboratories for process transfer, establishment and optimization of mRNA production processes and developing mRNA and LNP processes suitable for cGMP manufacturing.

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