Process & Analytical Development

Kudo’s Manufacturing Sciences & Analytical Technology laboratories enable the development and transfer of manufacturing technologies from external partners to our facility. We also produce non-GMP material for early stage preclinical and toxicology studies.

Process Development:
DNA Template
  • Bank generation/ characterization
  • High yield fermentation process development
  • pDNA purification process development
  • Process characterization and validation
  • From mg to 2 grams of R&D grade pDNA supply
Drug substance
  • Linearized or circular RNA
  • Non-replicating or self amplifying RNA
  • High efficiency IVT reaction development
  • RNA purification process development
  • Process characterization and validation
  • From ug to 200mg of R&D grade mRNA supply
Drug Product
  • Encapsulation technology development
  • LNP purification technology development
  • Formulation development
  • Filling control strategy
  • Packing & labeling
  • Process characterization and validation
  • Up to 100mg DS for LNP production for R&D study
  • Dossier writing
Analytical Development:

Analysis of plasmid

  • Restriction pattern
  • Sequence
  • Purity
  • Content
  • Residual protein
  • Residual DNA
  • Residual RNA
  • Bioburden
  • Endotoxin

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Analysis of mRNA

  • pH
  • Content
  • Sequence
  • Purity
  • mRNA Integrity
  • Capping efficiency
  • Poly A tail length
  • Residual pDNA
  • Residual protein
  • Residual NTPs
  • dsRNA content
  • Residual
  • Solvents
  • Bioburden
  • Endotoxin

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Analysis of LNP

  • pH
  • Osmolality
  • Encapsulation %
  • mRNA integrity
  • Lipid content
  • LNP site
  • LNP polydisperity
  • Potency
  • Sterility
  • Endotoxin
  • Subvisible particle
  • Extractable volume