Yaohai Bio-Pharma is a custom microbial Contract Development and Manufacturing Organization (CDMO) with advanced facilities (research and GMP grade). We are the CDMO partner of choice for your biologic pipelines throughout the biologics production process, including preclinical, phase 1, phase 2, phase 3, and commercial stages.
Our scientists can develop, manufacture, and release recombinant vaccines, therapeutic proteins/peptides, plasmid DNA, and mRNA following GMP standards.
If you need biological process development or GMP manufacturing services, Yaohai Bio-Pharma can help you with extensive experience, and professional regulatory guidance. We have formed a rational development route to minimize the CDMO timeline, as well as to mitigate any potential risks.
R&D
Yaohai Bio-Pharma has successfully introduced a modern factory with the industry's most sophisticated equipment and facilities for R&D. Our R&D team is highly experienced in strain engineering, microbial cell banking, fermentation, purification, formulation and analysis method development, technology transfer, and quality assurance.
Manufacturing Capacity
Yaohai Bio-Pharma has established five microbial fermentation, recovery, and purification production lines that comply with cGMP requirements, as well as two fill-finish automated lines for vials and pre-filled syringes. The fermentation scales available range from 10L to 100L, 500L, 1000L, and 2000L. Vials filling specifications are 1ml to 25ml, and pre-filled syringes filling specifications are 1-3ml.
Quality Control
All the deliverables are released under stringent quality standards, including microbial cell banks, drug substances, and drug products of plasmid DNA, mRNA, recombinant proteins, or peptides.
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