Microbial CRDMO Solutions with excellence in quality and global regulatory compliance
Recombinant Protein
Recombinant proteins are produced through recombinant DNA technology using microbial expression systems such as E. coli and yeast expression systems. They are widely used in therapeutic proteins, diagnostics, cytokines, enzymes, growth factors, and other biopharmaceutical applications.
Yaohai Bio-Pharma provides comprehensive recombinant protein expression and production services for a broad range of protein modalities. As an experienced protein production service provider, we support strain development, process optimization, protein purification, analytical characterization, and GMP manufacturing. With a well-established CRDMO platform and extensive project experience, we provide custom protein production solutions to meet diverse requirements across every stage of recombinant protein projects.
Yaohai Bio-Pharma leverages integrated CMC development and cGMP manufacturing capabilities to support recombinant protein production using advanced microbial expression systems, including E. coli expression and yeast expression systems. We select the optimal host platform based on protein characteristics, yield requirements, and downstream development needs.
Recombinant Protein Expression Systems
Leveraging advanced microbial expression systems and integrated CRDMO capabilities, Bio-Pharma supports the development, scale-up, and manufacturing of diverse recombinant protein modalities for research, clinical, and commercial applications.
Platform Capabilities: We provide tailored microbial expression and purification solutions for hormone and metabolic biologics. Leveraging advanced fermentation, protein refolding, and purification technologies, our platform enables the scalable manufacture of recombinant insulins, growth hormones, GLP-1 analogues, PTH, glucagon, and leptin with high yields, exceptional purity, and consistent product quality from development through commercial production.
Platform Capabilities: Recognizing that different types of recombinant vaccines demand highly distinct development approaches, our platform supports diverse virus-like particle (VLP) production and vaccine antigen expression. We leverage our robust yeast expression system and advanced fermentation scaling to overcome manufacturing bottlenecks for complex macromolecular structures.
Platform Capabilities: Accelerate your immunotherapy and cell culture pipelines with our high-yield cytokine production capabilities. Utilizing optimized E. coli and microbial expression systems, we achieve premium biological activity and exceptional purification benchmarks, consistently reducing endotoxin levels to <1 EU/mg.
Service Platform
With a mature microbial CRDMO platform specializing in E. coli and yeast expression systems, we provide comprehensive end-to-end services. From microbial cell banking and robust protein process development to GMP manufacturing and global IND/BLA regulatory support, we are fully equipped to accelerate your drug pipelines from R&D to commercialization.
End-to-End Microbial CRDMO Service Platform for Recombinant Proteins
Yaohai Bio-Pharma Offers One-Stop Recombinant Protein CRDMO Solutions
Optimized workflows using mature expression technologies to significantly reduce development timelines.
Scalable GMP Protein Production Capabilities
Flexible and scalable production capacities ranging from 50L to 2,000L.
Two aseptic fill & finish lines: Supporting liquid vials, lyophilized vials, and pre-filled syringes/cartridges.
High-yield, high-purity protein expression optimized for commercial-scale manufacturing.
Global GMP-Compliant Quality Management
Full compliance with rigorous global Pharmacopoeia and GMP standards.
Comprehensive lifecycle quality control, including rigorous stability studies strictly under ICH guidelines.
Stringent risk management frameworks to ensure uncompromising product safety and efficacy.
End-to-End Protein Production
Seamless transition from early-stage R&D through to commercial GMP manufacturing.
Full regulatory and manufacturing support for all clinical phases (I/II/III) and MAH applications.
Integrated, cross-functional project management to ensure timely milestone achievements.
Accelerated Tech Transfer & Cost Efficiency
Dedicated CRDMO expert teams providing agile and responsive support.
Cost-efficient process innovations designed to optimize your overall manufacturing budget.
Accelerated, seamless tech transfer protocols to speed up your time-to-market.
Recombinant Protein CRDMO Service Cases
Case Study 1: Interleukin (Cytokine) ProductionExpression System: E. coliProcess Optimization Benchmarks:
Before: Characterized by low expression yields, poor purification efficiency, and high endotoxin content.
After: Achieved high-yield expression (>10 mg/g of strain) with endotoxin reduced to <1 EU/mg and purity exceeding 98% (validated via SEC-HPLC).
Case Study 2: Proteins for Gene EditingExpression System: E. coliProcess Optimization Benchmarks:
Accelerated Timelines: Shortened the overall protein process development cycle significantly.
Robust Scale-up: Demonstrated exceptional process stability and consistency for seamless manufacturing scale-up.
Premium Quality: Secured high purity (>98%) using a mature multi-step purification platform.
Recombinant Protein FAQs
What is the difference between recombinant protein and natural protein?Natural proteins are directly extracted from biological tissues or fluids, which often limits their yield and purity due to finite raw material supplies and endogenous contaminants. In contrast, recombinant protein expression technologies allow the target gene to be inserted into engineered host strains, enabling precise control over protein structure and large-scale development.Because they are produced in controlled environments like a yeast expression system or E. coli, recombinant proteins better satisfy the requirements for high consistency and safety in drug development. This manufacturing approach not only supports rapid scalability from R&D to commercialization but also ensures that every recombinant protein drug candidate meets rigorous purity standards.What specific types of therapeutic proteins has Yaohai Bio-Pharma successfully developed?Our project portfolio includes a wide range of molecular formats, demonstrating our versatility in microbial protein production. We have extensive experience in producing recombinant growth hormones and recombinant insulin, focusing on precise protein folding and post-translational processing to ensure clinical efficacy.Additionally, our platform supports the development of complex recombinant enzyme candidates and various cytokines. By leveraging our established purification benchmarks, we ensure that these diverse proteins meet the high-purity requirements necessary for therapeutic and diagnostic applications.What are the core technical advantages of your microbial CRDMO platform?Our platform specializes in high-quality recombinant protein production utilizing E. coli and yeast expression system technologies (including Pichia pastoris). We implement Quality by Design (QbD) to define Critical Quality Attributes (CQA) and Critical Process Parameters (CPP) via Design of Experiments (DoE). This data-driven approach guarantees high expression yields, uncompromising batch-to-batch consistency, and significantly minimized risk during tech transfer.Can your manufacturing facilities support the transition from R&D to commercial scale?Yes, we provide an end-to-end recombinant protein expression service that spans from early R&D to full-scale commercial production. Our facility features scalable GMP protein production capacities from 50L to 2,000L, along with dedicated drug product lines for liquid vials, lyophilized vials, and pre-filled syringes to flexibly meet your diverse commercial milestones.
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.
