Menu
End-to-end microbial CRDMO solutions for biopharma and biotech companies across six biologic modalities, from process development to GMP manufacturing and regulatory readiness.
Integrated CRDMO support from strain development and process development to GMP manufacturing and global regulatory support.
End-to-end CRDMO solutions from plasmid development to commercialization, including process optimization, GMP manufacturing, and regulatory support.
Integrated development and manufacturing support enabled by microbial expression systems for this emerging antibody format.
Comprehensive CRDMO support covering process development, analytical testing, scale-up, and GMP-compliant manufacturing.
Focused process development and GMP manufacturing support for vaccine pipelines using microbial expression platforms.
Custom support for research-grade preparation, process development, and quality control across the product lifecycle.
Our integrated service platforms are designed to support biologics programs from early-stage development through manufacturing readiness across multiple modalities.
Explore Yaohai Bio-Pharma’s integrated microbial CRDMO platform for biologics development, combining process development, GMP manufacturing, quality assurance, and global regulatory support.
Backed by a track record of hundreds of successful projects, Yaohai supports projects from preclinical development through Phase I, Phase II, and Phase III clinical stages.
Our service network spans CMC process development, GMP manufacturing, quality control, global regulatory affairs, and quality assurance to help streamline project execution across key development milestones.
Our GMP manufacturing platform is designed to support high-quality production of drug substances and drug products for clinical and commercial applications.
Our quality systems support analytical testing across raw materials, in-process control, release testing, and stability studies, with QA practices aligned with ISO, ICH, and GMP expectations.
Our regulatory platform is structured to support global IND and BLA submissions through CTD documentation, strategic consulting, and agency communication support.
Yaohai’s scientists and cross-functional experts work together to provide technical support, project coordination, and execution tailored to microbial CRDMO projects.
Our manufacturing facilities are designed based on the Quality by Design (QbD) philosophy. Our production lines comply with NMPA, FDA, and EU GMP standards, fully supporting global regulatory filings. Furthermore, our facilities have successfully passed multiple rigorous audits by regulatory bodies including the FDA, EMA, and European QP audits, establishing an internationally aligned GMP compliance system.
Yaohai Bio-Pharma supports six key biologic modalities, including recombinant proteins, plasmid DNA, single-domain antibodies (sdAb), vaccines, mRNA, and circRNA.
Our extensive experience spans multiple clinical stages, currently supporting 9 Phase III clinical projects, 15 Phase II clinical projects, and over 100 IND and Phase I clinical projectss.
Yes. Our global regulatory affairs platform has proven international experience, successfully supporting 7 US-China dual-filing projects, 2 European regulatory submissions, and 2 Australian registration projects.
Through rigorous internal benchmarking and operational excellence, our advantages include:
oCost & Time Savings:
Yaohai provides integrated microbial CRDMO support across multiple development and manufacturing stages, with capabilities spanning CMC process development, GMP manufacturing, quality control, quality assurance, and global regulatory affairs.
Yes. Yaohai’s platform structure includes process development and GMP manufacturing capabilities designed to support the progression of projects from early-stage development to manufacturing readiness.
We operate robust, commercial-ready GMP manufacturing facilities:
Yaohai’s quality control platform supports analytical testing across raw materials, in-process control, release testing, and stability studies, while its quality assurance platform is built around ISO, ICH, and GMP-aligned practices.
Yaohai Bio-Pharma delivers tailored solutions for global clients, meeting diverse project requirements with excellence and efficiency.
Proven track record of over 100 successful projects, spanning preclinical studies and Phase I/II/III clinical trials, including US–China dual submissions and Australian regulatory filings.
A robust GMP-aligned quality system with standardized SOPs, fully compliant with global regulatory guidelines across the entire product lifecycle.
Powered by industry-leading scientists and cross-functional experts, our team delivers CRDMO projects with speed, precision, and deep technical insight.
