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Drug Substance
Manufacturing
Canton Biologics operates an integrated manufacturing facility with full Drug Substance (DS) and Drug Product (DP) capabilities, offering over 13,000 L of bioreactor capacity and an annual output of 200+ batches. The site is GMP-compliant with NMPA, FDA, and EMA standards and has passed EU QP audit.
Equipped with 50–2000 L single-use bioreactors and multiple aseptic fill-finish lines—including vial (liquid and lyophilized), PFS, nasal/throat spray, and BFS—the facility supports development from preclinical stages to commercial production.
Capabilities cover proteins, viral vectors, and cell-based products, supported by multiple upstream platforms and extensive single-use technologies to ensure flexible and efficient manufacturing.
14,000㎡
Mammalian Manufacture
12,000㎡
Microbial Manufacture
Flexible Facilities
Risk-driven Technology Transfer Platform

Identify risks and define control strategies for transfer and scale-up based onsystematic process understanding and gap analysis.

Leverage mature platform technologies and extensive project experience toprovide verifiable and reproducible technical support for risk control.

Deliver customized transfer and production solutions for complex proteinsand advanced technologies.

Single-use Technology-driven Flexible Manufacturing Platform

Compatible with multiple equipment brands and scales, enabling efficientand flexible scheduling to optimize productivity and cost-effectiveness.

Offers stricter contamination control, stronger compliance, and simplifiedoperations, ensuring higher product quality.

Technology Transfer Project Team
Document Transfer
Assess and Formulate a Scheme
Gap and Risk Analysis
Bill of Materials(BOM)
Transfer Testing
Production and Validation
Transfer Report
Capacity Allocation

Production Modes

Production Lines

Annual Capacity(batches)

Stirred-tank bioreactor (50/200/500L)

4X 96

Stirred-tank bioreactor (2000L)

5X 85

Orbital Shaker Bioreactor (250/2500L)

2X 18

Perfusion Culture (5OL/200L)

2X 8-12

Adherent cell culture(128L)

1X 36
Microbial 50L–500L
Stainless Steel Production Line
The 500L downstream production area is classified as a hazardous area (Ex-rated), i.e., a Class A workshop equipped with explosion-proof equipment. The area contains a low-pressure chromatography column for capture and intermediate purification of peptide products, as well as a DAC (Dynamic Axial Compression) high-pressure liquid chromatography column for final polishing. Additionally, the bulk drug substance workshop is equipped with a freeze dryer (lyophilizer) to enable long-term storage of the bulk drug substance as lyophilized powder.
Peptides (Semaglutide, Dulaglutide, Insulin, etc., recombinant proteins)