Yaohai Bio-Pharma has the cutting-edge microbial CRDMO (Contract Development and Manufacturing Organization) platform, built upon E. coli and yeast expression systems. Yaohai offers a one-stop solution encompassing strain development, primary cell bank (PCB), master cell bank (MCB), and working cell bank (WCB) construction, strain preservation, genetic and storage stability studies, and comprehensive quality testing and regulatory support.
The service is designed to help clients efficiently advance their biologics programs—from gene to GMP-compliant cell banks—while meeting global regulatory standards. All MCB and WCB construction services are carried out in independent GMP-certified facilities, ensuring biosafety, contamination control, and product integrity.
E. coli Expression System
The E. coli expression system remains one of the most widely adopted and cost-effective expression technologies for recombinant protein production. It offers a well-characterized genetic background, rapid cell growth, high expression yield, excellent stability, and robust resistance to contamination.
E. coli systems are particularly advantageous for producing non-glycosylated proteins, such as plasmid-based products, peptide hormones, and cytokines, making them the first choice for high-efficiency recombinant protein expression.
Yeast Expression System
The yeast expression system is widely used in industrial biomanufacturing, offering the combined benefits of prokaryotic simplicity and eukaryotic functionality. It enables rapid proliferation, high-density fermentation in cost-effective media, and efficient secretion expression, significantly reducing downstream purification costs. Its glycosylation capability also makes it suitable for producing a wide range of enzymes, hormones, and therapeutic proteins used in recombinant biopharmaceutical applications.
End-to-End Microbial Cell Banking Solutions
Yaohai Bio-Pharma provides a comprehensive, integrated service process that includes:
- Strain design, construction, and optimization
- Clone screening and characterization
- PCB, MCB, and WCB establishment (MCB/WCB constructed in GMP-certified facilities)
- Genetic stability and storage stability studies
- Full-scale quality control and documentation support
Average construction timeline: 4–6 months (excluding long-term stability studies).
Service Highlights
- One-Stop CDMO Platform – From strain construction and clone screening to three-tier cell bank development and testing, Yaohai provides a seamless and compliant service chain.
- Dedicated GMP Facilities – Independent GMP workshops for MCB/WCB construction prevent cross-contamination and ensure regulatory compliance.
- Versatile Preservation Options – Multiple strain preservation methods available, including glycerol stock, liquid nitrogen storage, and lyophilization, supporting flexible and off-site storage needs.
- Comprehensive Quality Testing – In compliance with pharmacopeial and regulatory requirements, including strain passage and storage stability testing.
- Regulatory & Registration Support – Internal regulatory experts assist clients with biologic product registration and submission processes.
- Virtual GMP Audit Access – Clients can access online GMP audit portals and 360° VR walkthroughs of Yaohai’s GMP facilities.
- Transparent Project Communication – Periodic project meetings are scheduled to share updates, milestones, and data-driven progress reports.
About Yaohai Bio-Pharma
Yaohai Bio-Pharma is a CRDMO with over a decade of experience in microbial expression systems. Focused on recombinant proteins, nucleic acid drugs, nanobodies, plasmid DNA, and novel vaccines, Yaohai provides full-lifecycle solutions from R&D to commercial manufacturing. The company is committed to building an open and integrated CRO/CDMO/MAH platform that drives innovation from discovery to commercialization, serving as a trusted partner to global biopharma companies.
