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Therapeutic IVT RNA Development

VectorBuilder offers comprehensive CRO services for the development of RNA therapeutics including vaccines, gene replacement, chimeric antigen receptor (CAR), and gene editing. Our team of experts understand key considerations for therapeutic design and process development, and can utilize their know-how to enhance the efficacy, safety, and manufacturability of RNA drugs. For large-scale manufacturing of RNA therapeutics, check out our CDMO services.

Talk to Our Experts
IVT Vector
Design & Cloning
IVT RNA Production
LNP Encapsulation
Quality Control (QC)
Functional Validation

IVT Vector Design & Cloning

  • Royalty-free IVT backbone with no IP constraints for commercial use
  • Proprietary sequence optimization for optimal expression
  • Robust cloning and transcription of 120 nt (and longer) polyA tail

IVT RNA Production

  • As fast as 5 weeks from vector cloning to LNP encapsulation
  • Synthesis of up to 10,000 nt mRNA and saRNA, and 5,000 nt circRNA from ug to gram scales
  • High capping efficiency (up to 99%) by co-transcriptional or enzymatic methods
  • Various modified nucleotide options: m1Ψ, m5C, 5moU, etc.
  • Proprietary purification process to efficiently remove impurities
  • Comprehensive QC panel
  • We offer cell-free production of IVT template DNA that greatly shortens the production time for large-scale IVT RNA manufacturing.

LNP Encapsulation

Visit our LNP Encapsulation service page for more details.

Quality Control (QC)

VectorBuilder offers a full spectrum of QC assays for IVT RNA. Default QC items (marked with √) are always performed while optional QC items are performed depending on individual project needs.

Attribute QC assay Research-grade GMP-like
Identity mRNA sequence Sanger sequencing
mRNA length Denaturing agarose gel electrophoresis
Capillary gel electrophoresis (CGE) Optional
General/physical property mRNA concentration UV spectrophotometry
RiboGreen assay Optional
Appearance Visual inspection Optional
Potency Gene expression In vitro translation followed by Western blot Optional Optional
Cell transfection Optional Optional
Safety Sterility Bioburden test Optional
Mycoplasma Culture method Optional
qPCR Optional Optional
Endotoxin Kinetic chromogenic assay (KCA) Optional
Purity mRNA integrity Denaturing agarose gel electrophoresis
Capillary gel electrophoresis (CGE) Optional
A260/280 UV spectrophotometry
Capping efficiency LC-MS Optional
PolyA analysis LC-MS Optional
Residual dsRNA Dot blot assay Optional
Residual plasmid DNA qPCR Optional
Residual protein NanoOrange assay Optional
Residual solvents Gas chromatography Optional Optional
Circularization efficiency (for circRNA) Denaturing agarose gel electrophoresis Optional
Capillary gel electrophoresis (CGE) Optional

Functional Validation

Our scientists and technical team can help you with functional study to optimize your IVT RNA design for therapeutic purpose, including:

  • Assessing the effects of sequence optimization of various vector components (UTR, coding sequence, polyA, Kozak, etc.) in vitro and in vivo
  • Testing IVT RNA for various applications, such as antigen presentation, antibody expression, CAR expression, and CRISPR
  • Assessing LNP gene delivery efficacy and safety using animal models including rodents and non-human primates (NHPs)