GMP Manufacturing Platform

From microbial fermentation to aseptic fill and finish

Our Services

Integrated GMP Manufacturing Solutions

Yaohai Bio-Pharma offers end-to-end CRDMO services from preclinical to commercial stages. With GMP-compliant facilities (NMPA, FDA, EMA), we offer flexible bioreactor scales ranging from 50L to 2000L, as well as advanced aseptic drug product lines for various vials and pre-filled syringes, and cartridges.

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Reach out to learn how our microbial CRDMO services can support your project.

What we do

End-to-End GMP Manufacturing Platform

01.

Drug Substance Manufacturing

01.Drug Substance Manufacturing

Yaohai Bio-Pharma operates five drug substance production lines,
offering GMP-compliant bioreactor scales from 50L to 2000L in full compliance with NMPA, FDA, and EMA standards
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02.

Drug Product Manufacturing

02. Drug Product Manufacturing

Yaohai Bio-Pharma operates a 2,000㎡ aseptic drug product facility,
with production lines designed to meet EU and US GMP requirements
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Why Choose us

GMP Manufacturing Platform
with High Flexibility

GMP-compliant Drug substance production area over 10,000㎡.

Multi-scale (50L-100L, 200L, 500L, 1000L and 2000L) fermentation platform.

Upstream: 5 drug substance production lines, with a production capacity of 7500L, and fermentation equipment of various specifications.

Downstream: 5 purification production lines, equipped with various chromatography and ultrafiltration systems.

Reasonable plant design, D/I/O/PQ-verified air-conditioning and water system, etc.

Compliance QA, operational QA, and validation teams are in place to ensure the efficient implementation.

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Production Capacity

1.Providing aseptic fill-and-finish solutions for vials and pre-filled syringes and cartridges at multiple scales,
supporting projects from clinical development to commercial supply.

Liquids Vials

1mL–25mL
10 million units/year

Lyophilized Vials

1mL–25mL
5 million units/year

Pre-filled Syringes & Cartridges

1mL & 3mL
10 million units/year

FAQ

Frequently Ask Questions

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.

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.