Kudo Biotechnology

Kudo Biotechnology is a global Contract Development and Manufacturing Organisation (CDMO) that offers comprehensive, end-to-end mRNA manufacturing solutions. With state-of-the-art clinical GMP manufacturing facilities and laboratories located in Boston, China, and Singapore, Kudo Biotechnology specialises in the production of plasmid DNA (pDNA), messenger RNA (mRNA), and lipid nanoparticles (LNP). The company distinguishes itself as a one-stop shop for all mRNA manufacturing needs, streamlining processes to eliminate bottlenecks and facilitate ease in Chemistry, Manufacturing, and Controls (CMC). Kudo’s expedited timeline of 6.5 months from sequence to GMP mRNA-LNP surpasses industry standards while ensuring superior quality and full compliance with global regulatory requirements.

Kudo Biotechnology has a proven track record of successfully achieving end-to-end GMP manufacturing, with numerous products entering clinical trials and multiple batches of process validation following international technology transfer. The facilities boast an industry-leading cGMP manufacturing capacity, capable of producing up to 50 GMP batches annually. Kudo maintains strong technology partnerships that provide access to essential scale-up expertise and production know-how. Furthermore, a comprehensive quality management system boasting Quality Assurance and Quality Control (QA/QC) capabilities is crucial for meeting the compliance demands of major regulatory agencies, thereby delivering products to clients around the globe.

Services include:
- mRNA manufacturing
- LNP formulation
- Plasmid DNA production
- Process validation
- Quality assurance and control
- Clinical GMP manufacturing
- Technology transfer
- Regulatory compliance support

Kudo Biotechnology continues to set the bar for quality and speed in the pharmaceutical industry, securing its position as a key player in the global market. For more information, please visit kudobio.com.