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cGMP mRNA-LNP Manufacturing Services for Clinical and Commercial Production - ProBio

mRNA-LNP GMP Manufacturing

Accelerated production of high quality mRNA with LNP encapsulation, analytical testing, and GMP manufacturing support.
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Manufacturing Capabilities for LNP Encapsulation

Reliable LNP Manufacturing at Any Scale

ProBio delivers pro-grade and GMP-grade LNP encapsulation with support for complex formulations, high drug concentrations, scalable production up to 50 g, and precise particle size control to ensure product quality, consistency, and successful clinical advancement.

Optimized LNP Manufacturing

Utilizing advanced microfluidic and T-mixing technologies, ProBio's universal LNP platform enables the production of high-quality lipid nanoparticles with excellent consistency, scalability, and control, supporting programs from early development through GMP manufacturing.

Customized LNP Formulations Built for Success

ProBio helps developers overcome delivery challenges through customized LNP formulation development and commercial formulation expertise, enabling efficient nucleic acid delivery, scalable manufacturing, and accelerated therapeutic development.

From Plasmid DNA to mRNA-LNP in 9 Weeks

mRNA-LNP Manufacturing workflow Development timeline from preclinical studies through BLA filing and FDA approval, with Pro Grade, IND CMC, GMP Grade, and BLA CMC manufacturing stages. Preclinical Studies ProcessDevelopment IND–EnablingCMC IND Filing/FDAApproval Early StageClinical Late Stage Clinical BLA Filing/FDAApproval Pro Grade IND CMC GMP Grade GMP Grade BLA CMC GMP Grade

Manufacturing Capabilities for mRNA, saRNA, and circRNA

mRNA Development

  • Capping Process: Co-capping; Enzymatic capping
  • High purity : >95%
  • High capping efficiency: >95%
  • High yield: 10 mg/mL
  • High mfg. recovery: 60-80%
  • DS concentration: 1-5 mg/mL
  • High expression; feasible process

saRNA Service

  • Length: 8~12k
  • High purity : >95%
  • High capping efficiency: >95%
  • High yield: 6-8 mg/mL
  • High mfg. recovery: >50%
  • Extended expression; low-dosage

circRNA Service

  • Circularization process: Group I/II Intron self-splicing; T4 RNA ligase
  • Manufacturing process: Enzyme-based or chromatography-based process
  • High purity: >90%
  • High yield: ~5 mg/mL
  • Scalable process for efficient circRNA purification
  • Stable structure; no capping & tailing
ProBio supports mRNA & LNP manufacturing services from preclinical, IND-enabling, clinical phases to commercialization production.

Case Studies

Case study: High-Performance LNP Formulations with Consistent Critical Quality Attributes

High-Performance LNP Formulations with Consistent Critical Quality Attributes

Case study: High-Yield, Scalable mRNA Manufacturing Platform Supporting Diverse Transcript Lengths

High-Yield, Scalable mRNA Manufacturing Platform Supporting Diverse Transcript Lengths

Resources

ProSpeed single B cell antibody discovery service brochure cover

WHITE

PAPER

Challenges and Solutions in the Poly(A) Control for Plasmid and mRNA

Learn about how consistent control strategies ensure poly(A) length and purity, from upstream plasmid to downstream production.
Learn More
ProBio biologics discovery services brochure for multiple modalities

WHITE

PAPER

CircRNA White Paper

Learn about the 4 biggest barriers for circRNA manufacturing — Sequence design, circularization efficiency, impurity control, scalable production.
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WEBINAR

mRNA & CircRNA-tLNP Webinar 

Learn how RNA therapeutics and targeted lipid nanoparticles (tLNP) are opening new possibilities for engineering CAR-T cells directly in the body.
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Flyer: Manufacturing Plasmids for mRNA Vaccines

FLYER

Manufacturing Plasmids for mRNA Vaccines

Learn about an integrated and accelerated one-stop CDMO solution for IND filing: design, manufacturing, and downstream application for mRNA vaccines.
Learn More
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Request a Quote

Seamless mRNA-LNP manufacturing starts today. Contact us to get started.
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Frequently Asked Questions