Microbial CRDMO Solutions with excellence in quality and global regulatory compliance
Nano-body
Yaohai Bio-Pharma delivers end-to-end Single Domain Antibodies development and VHH antibody production services through rigorously optimized E. coli and yeast microbial platforms. As a dedicated CRDMO, we support the entire lifecycle of VHH single domain antibody manufacturing, offering flexible GMP scale-up from 50 L to 2000 L. Our standardized CMC processes ensure high-yield, consistent expression of your camelid VHH assets, providing the clinical and commercial manufacturing capacity necessary to accelerate global regulatory submissions, including IND and BLA fillings.
Yaohai Bio-Pharma integrates scalable R&D and manufacturing capabilities specifically designed for nano antibody therapeutics. Our microbial expression systems are optimized to handle the unique folding and stability requirements of a vhh domain antibody, providing comprehensive services from early-stage discovery to commercial-scale production.
By aligning DoE-based process development with flexible GMP manufacturing, we streamline the transition from early-stage screening to commercial production, significantly reducing IND filing timelines.
Microbial Expression Systems for VHH Antibodies
Unlike conventional full-length antibodies or larger fragments like fab fragment (~50 kDa) and scfv fragment (~30 kDa), the compact nature of VHH allows for highly efficient, non-glycosylated expression in E. coli and yeast. This significantly reduces production costs and shortens the development cycle compared to mammalian cell cultures.
Service Platform
Yaohai Bio-Pharma is your dedicated CRDMO partner for scalable Single Domain Antibodies development and VHH antibody production. Utilizing robust E. coli and yeast-based expression systems, we deliver end-to-end services—from strain construction and process development to GMP-grade commercial manufacturing and global IND/BLA support. We integrate advanced analytical and quality systems to ensure your VHH assets meet international regulatory standards.
Microbial CRDMO Platform for Single Domain Antibodies Development
Leveraging our advanced E. coli and yeast expression systems, Yaohai Bio-Pharma provides a seamless, end-to-end CRDMO for nanobody development and VHH antibody production from plasmid construction to GMP manufacturing.
One-Stop Nanobody Development & VHH Antibody Production Solutions
From early-stage screening to commercial-scale manufacturing, our platform provides comprehensive, fully integrated services tailored to the unique requirements of camelid nanobodies.
Microbial Strain Development & Screening for VHH Antibodies
Microbial Cell Banking (PCB/MCB/WCB) for Single Domain Antibodies
Upstream Process Development for Antibody Fragments
High-Yield Downstream Purification of VHH Domain Antibodies
Advanced Formulation Development for Single Domain Antibodies
GMP Manufacturing of Clinical-Grade Nanobodies
Sterile Fill and Finish (Lyophilized Vials, Liquid Vials, Prefilled Syringes)
Quality Control & Analytical Testing for VHH(Single Domain Antibodies )
Global Regulatory Affairs & IND/BLA Submission Support
Versatile Expression Platform for Antibody Fragments
While our microbial platform is highly optimized for camelid VHH, it is also engineered to tackle the common expression challenges of various antibody fragments.
Single Domain Antibodies (VHH): We achieve ultra-high yield and superior stability for VHH, overcoming the limitations of mammalian systems.
scFv & Fab Fragments: Unlike traditional platforms where scFv fragments often face severe aggregation and Fab fragments struggle with low yields, our proprietary E. coli and yeast refolding technologies ensure high solubility and correct folding for all your fragment designs.
Service Highlights
Advanced Process Development for Single Domain Antibodies Development
Based on QbD (Quality by Design), we implement DoE (Design of Experiments) tailored for Single Domain Antibodies development. This identifies Critical Quality Attributes (CQA) and establishes Critical Process Parameters (CPP), ensuring robust product quality and high yields for your Single Domain Antibodies projects.
Extensive Experience in VHH Antibody & Fragment Expression
Successfully supported hundreds of projects covering preclinical research, Phase I-III clinical trials, and regulatory filings in the U.S., China, and Australia. Our expertise spans diverse formats, including VHH antibody, scFv fragment, Fab fragment, and other complex antibody fragment modalities.
Expert Support for VHH Antibody Production
Yaohai Bio-Pharma’s CRDMO services are delivered by a specialized team with proven expertise in VHH antibody production, significantly reducing both time and investment costs. Our dedicated PM team provides full-lifecycle project management for VHH antibodies, proficient in identifying critical paths and mitigating risks.
Robust Manufacturing for VHH Domain Antibodies
Flexible scale-up from 50L to 2000L, optimized specifically for VHH antibody and VHH single domain antibody expression systems. We offer equipment for multiple production scenarios alongside two commercial drug product production lines (lyophilized vials, liquid vials, prefilled syringes).
Comprehensive Quality System for Nano Antibody Therapeutics
Full-spectrum quality management system aligned with the latest GMP and global regulatory standards, ensuring sustained product consistency for every batch of your nano antibody therapeutics.
End-to-End CRDMO Platform for Single Domain Antibody Development
From sequence discovery and process development to commercial manufacturing — delivering integrated CRDMO services exclusively tailored for Single domain Antibodies development and comprehensive antibody solutions.
VHH Antibody CRDMO Case Study
Discover how our specialized microbial platform delivers exceptional purity and scale for therapeutic single domain antibodies.
Nano Antibody FAQs
How does your platform address the expression yields and stability issues of different antibody fragments?While traditional microbial platforms struggle with the low yields of Fab fragments and severe aggregation of scFv fragments, Yaohai Bio-Pharma specializes in optimized refolding and purification strategies. For VHH, our platform consistently delivers high-yield, high-solubility, and correctly folded Single Domain Antibody ready for downstream applications.Are your facilities approved for global regulatory filings (FDA/EMA)?Yes. Our comprehensive quality system aligns strictly with international GMP standards. All vhh antibody production and cell banking processes provide fully traceable CMC data packages to seamlessly support your IND/BLA submissions to the US FDA, EMA, and NMPA.How does Yaohai Bio-Pharma handle IP (Intellectual Property) protection for custom nanobody projects?As a pure-play CRDMO with no proprietary therapeutic pipeline, we eliminate potential IP conflicts at the source. Strict confidentiality agreements, clear IP ownership terms, and dedicated project teams ensure strong protection of client information. Robust data security systems and controlled facility access safeguard proprietary information throughout the project lifecycle.How do you ensure low endotoxin levels during the purification of microbially expressed nanobodies?Endotoxin control is a critical pillar of our downstream platform. By combining proprietary column washing protocols, dedicated equipment cleaning validation (CIP), and advanced anion exchange chromatography, we consistently control endotoxin levels to <50 EU/mg protein (as demonstrated in our Single Domain Antibody case study). This ensures all delivered antibody fragments meet the strict safety criteria required for preclinical studies and clinical trials.What is Yaohai’s track record regarding tech transfer and scalability for VHH antibody production?We bridge the gap between lab-scale discovery and commercial success. Our platform features fully scalable, geometrically integrated microbial fermenters ranging from 7L, 50L, to 2000L. Supported by a seasoned tech transfer team and structured QbD/DoE frameworks, we ensure a seamless, risk-free transition from pilot batches to large-scale VHH antibody production with consistent quality profiles.
Yaohai Bio-Pharma delivers tailored solutions for global clients, meeting diverse project requirements with excellence and efficiency.
Proven Project Excellence
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.
Regulatory Compliance Assurance
A robust GMP-aligned quality system with standardized SOPs, fully compliant with global regulatory guidelines across the entire product lifecycle.
Expert Team Support
Powered by industry-leading scientists and cross-functional experts, our team delivers CRDMO projects with speed, precision, and deep technical insight.
Unlike conventional full-length antibodies or larger fragments like fab fragment (~50 kDa) and scfv fragment (~30 kDa), the compact nature of VHH allows for highly efficient, non-glycosylated expression in E. coli and yeast. This significantly reduces production costs and shortens the development cycle compared to mammalian cell cultures.
