Facilities

Manufacturing

Kudo Biotechnology has built a state-of-the-art cGMP mRNA Pilot Manufacturing facility in Minhang, Shanghai. Spanning over 5,300m2, our facility accommodates two plasmid lines, three mRNA lines, two LNP bulk lines, and one drug product fill & finish line. These production lines fulfill manufacturing needs for preclinical through Phase 2 clinical trials, and our facility architecture has capacity to manufacture up to 40 million vials/ year.

50 batches/year

Existing Pilot Capacity

200 batches/year

Planned Commercial Capacity

Sep 2022

Initial Pilot

cGMP

Manufacturing Facility

5,300㎡

Total Area

2023 Q1

Operation-ready

LNP production system

Preparation ultrafiltration system

pDNA fermenter

Biosafety Cabinet

Isolator-aseptic ops

Small scale fermenter

Quality Control

Our Quality Control laboratory occupies 800m2 and is equipped with advanced equipment to conduct comprehensive sampling tests on all raw materials, intermediate, and final products, including monitoring of product stability at various temperatures.

Sterility test isolator

Dynamic light scattering spectrometer

Microplate reader

UPLC

Fragment analyzer

Process Development

Kudo's a Process Development Laboratory in Boston is expected to be ready by Nov 2023.

Virtual tour of our facilities