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Service/ Custom mRNA Synthesis
Overview

The emergence of mRNA vaccines, propelled by the COVID-19 pandemic, highlights the vast potential of mRNA in addressing unmet therapeutic needs. mRNA technology has achieved notable maturity in infectious disease vaccines and tumor immunotherapy. As a versatile platform, it has also driven significant advancements in in vivo and in vitro gene editing, cell therapy, protein replacement therapy, and regenerative medicine.

 

XGen's mRNA production platform streamlines the entire workflow, from gene synthesis to in vitro transcription, enabling the efficient production of high-quality, large-scale DNA templates and mRNA reagents. Our solutions are tailored to support mRNA vaccine development and therapeutic research, accelerating your innovation and discovery efforts.

Details
One-Stop Solution for All Your mRNA Needs
 
XGen’s solution for IVT mRNA manufacturing streamlines your workflow, from gene synthesis to mRNA production. Our IVT mRNAs are optimized using our proprietary production platform, ensuring high quality and expression efficiency.
 
Codon/UTR Optimization Gene Synthesis Cloning/Plasmid Synthesis mRNA Synthesis Lipid Nanoparticles Delivery

 

  • Codon optimization for protein expression offered every day for every gene
  • Codon optimization with >200 factors screened (patent)

 

  • 100 bp – 20,000 bp gene inserts
  • TAT as fast as 6 Bussiness Days to 14 Business Days
  • Gene synthesis with Poly(A)-built-in vector

 

  • Ready to use linearized plasmid DNA for IVT
  • Vectors encode a stable Poly(A) tail with a variance of ±5–10 nt

 

  • Customized RUO to preclinical grade mRNA service 
  • Advanced purification (Oligo dT, dsRNA removal) and a variety of QC options

 

 

  • Generic ionizable lipid formulation
  • Encapsulate 0.1- 30mg of mRNA, siRNA, miRNA,  DNA, and sgRNA delivery
  • LNP for gene editing
                   
Size/Scale Options 5' Cap Options Poly(A) Tail Options Modified NTP Options Purification Options

 

  • 100 bp – 20,000 bp sequences
  • 0.1mg to 1g scale

 

  • Cap0
  • Cap1 (Co-trascriptional or enzymatic)
  • Cap2 (Co-transcriptional)
  • Uncapped

 

  • 100 poly(A) tail (recommended)
  • Custom tail ≤ 120A

 

  • N1-Me-Ψ
  • 5moU
  • 5meC &  Ψ
  • Cy5-UTP or Thio-CTP
  • Unmodified
  • 5’-Biotin modified
  • N6-methyl-A
  • 5-Iodo-C, 5-Iodo-U

 

 

  • LiCl precipitation
  • Oligo dT purification
  • dsRNA removal
 
 
 

Quality Control and Specification

 

Category QC Test Method Specification RUO Default RUO Upgrade Preclinical
Default
Preclinical
Upgrade
Identification Appearance Visual Inspect Clear and free of foreign particles
RNA Length Capillary Electrophoresis Target ± 30% ×
RNA Length Agarose Gel Electrophoresis Expected size band detected × × ×
Poly A Length Enzyme digestion & LC-MS Target ± 5% ×
RNA concentration UV Absorbance Target ± 5%
PH pH meter Target ± 0.5 ×
Buffer Specification Client Spec N/A ×
Sequencing Sanger Sequencing >98% Alignment × × ×
Sequencing NGS by Illumina Q20 Ratio > 95% × × ×  
Purity A260/A280 Ratio UV Spec 1.70 ~ 2.30
Capping Efficiency LC-MS ≥ 90% ×
Size based purity Capillary Electrophoresis ≥ 75% ×
Impurity

Total Protein Residue

Nano Orange Assay ≤ 1% × ×
Plasmid DNA Residue qPCR ≤ 0.05% × × ×
dsRNA Slot-blot ≤ 0.1% × ×
Aggregate quantification RNA Aggregation Assay < 5% × × ×
Safety Endotoxin Semiquantitative < 10EU/mL × × ×
Endotoxin LAL endotoxin detection < 10EU/mL × ×
Bioburden Pour plate and spread plate assay <10 CFU/100mL × × ×
 
 
 
FAQs
 
What is the length limit of XGen's mRNA production capability?

We can make mRNA from 100 n.t. to 20,000 n.t. in length. 

 

What's the difference between RUO and preclinical grade mRNA?

For RUO grade mRNA, we use LiCl precipition method for purification. It is suitable for in vitro and in vivo proof of concept studies.

For preclinical grade mRNA, we use Oligo dT purification to improve RNA purity.

 

Can XGen provide GMP-grade mRNA?

Yes

 

Do you guarantee the yield of the mRNA?

Yes.

 

What concentratio of mRNA can you produce?

We provide mRNA at a concentration of 0.2-2 mg/mL by default. We can adjust the concentration to up to 4mg/mL upon customer's request

 

What buffer options does XGen offer for mRNA?

1mM sodium citrate (pH 6.5)

TE buffer (pH7)

RNase-Free water.

 

 

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