Company Overview

Kudo Biotechnology is a global mRNA CDMO company headquartered in United States, providing world-class end-to-end cGMP manufacturing solutions for mRNA companies.

mRNA Track Record

  • Full Suite of Solutions for Manufacturing, from pre-clinical to commercial product supply.
  • Successfully accomplished GMP manufacturing, with products in Human clinical trials.
  • Track record of international technology transfer, successfully completed multiple batches of process transfer through validation.

Dedicated and Unique

  • Globally-leading integrated mRNA CDMO, dedicated to deliver the fastest and most comprehensive services.
  • Specialized CDMO focusing on pDNA, Synthetic DNA, and mRNA Drug Substance, plus LNP, and fill finished Drug Products.

Operational cGMP Facility

  • Industry-leading manufacturing platform with the capacity to make up to 50 GMP batches / year with expansion plan.
  • Technology partnerships enable access to scale-up expertise and production knowhow of all classes of DNA templates.
  • Comprehensive QA/ QC capabilities and facilities meet global regulatory and compliance requirements.

Stage-appropriate process and analytical development services

  • Gene expression (UTR and Codon) optimization through construct design and modification.
  • Synthetic Cell Free DNA Template
  • High yield IVT reaction to maximum mRNA yield.
  • Robust platform purification processes for high recovery.
  • LNP formulation
  • Comprehensive analytical testing panels for in-process control, release testing and stability studies.