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Yaohai Bio-Pharma provides integrated GMP manufacturing services for biologics, supporting drug substance manufacturing and drug product manufacturing from clinical development to commercial supply. With GMP-compliant facilities aligned with NMPA, FDA, and EMA standards, we offer flexible bioreactor scales from 50 L to 2000 L and advanced aseptic fill&finish lines for vials, pre-filled syringes, and cartridges.
Reach out to discuss your pipeline and learn how our GMP production capabilities can support your project.
Our GMP manufacturing platform supports biologics production through integrated drug substance manufacturing and drug product manufacturing services for clinical and commercial supply.
Our GMP manufacturing platform combines scalable drug substance and drug product capabilities, GMP-compliant operations, and quality-focused systems to support efficient biopharmaceutical manufacturing.
Our GMP-compliant drug substance manufacturing area exceeds 10,000 m², supporting flexible biologics production at multiple scales.
We offer GMP production across 50 L, 100 L, 200 L, 500 L, 1000 L, and 2000 L fermentation scales to support different program needs.
Our upstream platform includes five drug substance production lines with a total fermentation capacity of 7,500 L.
Our downstream manufacturing platform includes five purification lines equipped with chromatography and ultrafiltration systems for biologics processing.
Our plant design includes DQ/IQ/OQ/PQ-qualified air-handling and water systems to support GMP manufacturing process control.
Our compliance QA, operational QA, and validation teams support efficient GMP implementation and ongoing quality assurance.
We provide aseptic fill-finish service for liquid vials, lyophilized vials, pre-filled syringes, and cartridges to support biologics production from clinical supply to commercial manufacturing.
Aseptic fill-finish capacity for liquid vials.
1mL–25mL
10 million units/year
Flexible fill-finish capacity for lyophilized vials.
1mL–25mL
5 million units/year
Drug product manufacturing capacity for pre-filled syringes and cartridges.
1mL & 3mL
10 million units/year
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Ut fames nibh euismod fermentum justo velit ultricies nunc duis placerat taciti. Torquent quam nisi integer fermentum accumsan litora. Efficitur potenti hac imperdiet laoreet vel vivamus placerat platea augue taciti. Dictum ultricies efficitur metus aliquet consectetuer pulvinar vivamus eget.
Ut fames nibh euismod fermentum justo velit ultricies nunc duis placerat taciti. Torquent quam nisi integer fermentum accumsan litora. Efficitur potenti hac imperdiet laoreet vel vivamus placerat platea augue taciti. Dictum ultricies efficitur metus aliquet consectetuer pulvinar vivamus eget.
Ut fames nibh euismod fermentum justo velit ultricies nunc duis placerat taciti. Torquent quam nisi integer fermentum accumsan litora. Efficitur potenti hac imperdiet laoreet vel vivamus placerat platea augue taciti. Dictum ultricies efficitur metus aliquet consectetuer pulvinar vivamus eget.
Ut fames nibh euismod fermentum justo velit ultricies nunc duis placerat taciti. Torquent quam nisi integer fermentum accumsan litora. Efficitur potenti hac imperdiet laoreet vel vivamus placerat platea augue taciti. Dictum ultricies efficitur metus aliquet consectetuer pulvinar vivamus eget.
Yes. Our quality systems are designed to comply with NMPA, FDA, EMA and TGA standards. We have completed hundreds of audits, demonstrating our rigorous commitment to global quality standards.
We offer a highly flexible, multi-scale production matrix. Our GMP drug substance facility features five independent upstream production lines with bioreactor scales at 50L, 100L, 200L, 500L, 1000L, and 2000L, providing a total fermentation capacity of 7,500L. This allows us to dedicate specific lines to your project and scale seamlessly as your demand grows.
Absolutely. We have a comprehensive technology transfer process and a robust risk control system in place. Our dedicated project management and quality teams work closely with you to perform gap analyses and ensure a smooth, compliant transfer of your process into our GMP facilities.
We maintain a comprehensive in-house quality control platform capable of over 50 specialized testing methods. Our QC testing covers physicochemical, biochemical, and microbiological parameters, including stringent controls for host cell proteins (HCP), host cell DNA (HCD), endotoxins, and overall product purity to ensure commercial-grade release.
