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Yaohai Bio-Pharma provides integrated CMC development services for biologics, including microbial strain development, bioprocess development, formulation development, analytical method development, and regulatory support from R&D to commercialization.
Right Card Description: Reach out to discuss your pharmaceutical pipeline and learn how our integrated CMC services can support your project.
We support biologics development with integrated microbial CRDMO capabilities, combining CMC expertise, scalable production capacity, GMP-aligned quality systems, and flexible collaboration models
We have supported more than 200 projects across preclinical research and Phase I, II, and III clinical development.
Our senior management and technical teams bring deep industry expertise in biologics development, process scale-up, and project delivery.
Our fermentation capacity ranges from 2 L to 2000 L, supporting projects across different development stages and manufacturing scales.
Our quality systems are aligned with GMP requirements and global regulatory standards, including NMPA, EMA, and FDA standards.
We tailor our collaboration approach to your project needs, helping improve agility, transparency, and development efficiency.
We provide integrated support from microbial cell banking and process development to GMP manufacturing and drug product development.
Projects Delivered
Fermentation Capacity
Clinical Development Support
Quality and Regulatory Systems
Learn more about our biologics-focused CRDMO capabilities, development platforms, and technical insights.
Explore our biologics-focused CRDMO modalities, including recombinant proteins, plasmids, nanobodies, and recombinant vaccines.
Learn more about our integrated CRDMO solutions, from CMC process development to commercial manufacturing support.
Read the latest company updates, industry insights, and technical articles related to biologics development.
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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.
Beyond standard recombinant proteins and peptides, our CMC capabilities extend to single-domain antibodies (sdAbs), plasmid DNA, mRNA, virus-like particles (VLPs), and recombinant vaccines.
We have extensive experience with a wide range of microbial hosts, including various E. coli strains (such as K-12 and B strains) and yeast systems like Pichia pastoris. We can also work with tailor-constructed strains or specific microbiota provided by our clients to meet unique project needs.
Our platform-based approach significantly shortens development cycles. For example, we can complete high-efficiency screening of high-expression strains within four weeks, and finalize complete fermentation process development and optimization within just 1.5 months.
We strictly adhere to the Quality by Design (QbD) concept from the very beginning of process development. By utilizing Design of Experiments (DoE) to identify critical process parameters (CPP), we ensure the robustness of the process, allowing for seamless scale-up from lab-scale (e.g., 30L) directly to our 2000L GMP bioreactors.
