mRNA Vaccine Manufacturing

Clinical and Commercial mRNA Manufacturing

Arranta Bio offers end-to-end manufacturing—from critical starting materials through mRNA and LNP production to aseptic fill—under one roof, accelerating the CMC path and transforming time to patients. Arranta has specialized, flexible manufacturing facilities engineered using the latest design principles to accommodate your specific needs while meeting U.S. and global regulatory requirements.

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Starting Materials mRNA mRNA Lipid Nanoparticles Aseptic Filling Quality Flexible Partnerships

Starting Materials

Arranta Bio has partnered to offer select starting materials process development and manufacturing services. Our manufacturing suites can accommodate:

cGMP-grade production in single-use fermentors
Harvest TFF and centrifugation
Lysis
Chromatography and filtration-based purification
Linearization

mRNA

cGMP manufacturing of mRNA is performed in Grade C suites and in compliance with the FDA Code of Federal Regulations (Part 21) and ICH guidelines. Our mRNA manufacturing suites can accommodate:

Plasmid linearization
Up to 50L cGMP clinical and commercial mRNA production, capping, tailing and DNA digestion—up to 100g scale
RNA purification including capture and/or other chromatography, buffer exchange and/or concentration

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mRNA Lipid Nanoparticles

cGMP production of lipid nanoparticle encapsulated mRNA is performed in suites engineered and designed to maximize safety in compliance with the FDA Code of Federal Regulations (Part 21) and ICH guidelines. Our LNP suites can accommodate:

Solvent based lipid emulsification
cGMP LNP production up to approximately 50 g depending on solvent volumes— mixing technology platforms including microfluidics, T-junction mixing, and jet mixing. Chromatographic or filtration based polishing or final formulation steps
Suite/equipment flexible for process specific needs

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Aseptic Filling

cGMP aseptic filling will be available at Arranta Bio from a dedicated Grade C manufacturing suite using Vanrx’s robotic system. The SA25 is an integrated, automated, gloveless robotic isolator combining all aspects of aseptic processing, with no operator intervention. Our cGMP filling capabilities will include:

cGMP aseptic filling of vials, syringes and cartridges
2 to 50 mL volumes
Up to 20,000-unit lot size

Quality

A quality culture and system are at the center of everything we do. Arranta Bio has a robust, phase-appropriate Quality Management System and we use best-practice software and systems for managing quality and ensuring compliance at every step.

cGMP compliance with 21 CFR 210 and 211, ICH guidelines, and FDA guidance
Use of best-practice software and systems (deviations, CAPA, change control, investigations, risk management), automated equipment monitoring and asset management, training, resource planning, data integrity and security
Regulatory submission support

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Flexible Partnerships

Arranta Bio offers flexible business models to meet the needs of your project, including:

Traditional CDMO, offering pay per batch with multi-product/multi-client suites, using Work Statements to reserve capacity.
Dedicated capacity, for customers with sufficient demand and a need to support supply through licensure. We offer flexible scheduling for multi-product use ramping up to maximum output with person-in-plant for technical oversight and fixed capacity access fee plus variable costs.
Custom manufacturing partnerships tailored to your program requirements. Learn more