Recombinant protein CDMO service
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Recombinant Protein Overview

Recombinant proteins are proteins obtained by recombinant DNA technology. The host cells used to produce recombinant proteins are mainly E.coli cells (prokaryotic expression system) and yeast cells (eukaryotic expression system).

Recombinant proteins have been widely used in therapeutic recombinant protein drugs and drug carriers, preventive recombinant protein vaccines, immunoassay reagents, diagnostic reagent development, etc., and play an important role in most popular research fields such as antibody drug target screening, CAR-T cell therapy, CDC conjugated drugs, enzyme preparations, influenza virus proteins, and cytokines.

Microbial Fermentation - Recombinant Protein CDMO Service Overview

In the field of recombinant protein services, Yaohaibio can provide one-stop CMC services for various types of recombinant proteins, including cytokines, carrier proteins, recombinant polypeptides, enzymes, allergens, VLPs, vaccines and other types of recombinant proteins.

Yaohaibio dedicates to developing a stable recombinant protein CDMO service platform, which can provide customers with whole life cycle services such as gene engineering strain construction, strain bank establishment, lab-scale process development/optimization, pilot-scale process scale-up production, IND application and clinical sample preparation, quality specification establishment, analytical method development/validation, quality management system establishment, NDA registration and application and commercial production (MAH) to satisfy customers with commercial requirements for different stages of recombinant protein drug product development. With rich experience in process development and production, we are committed to serve the customers in efficient and high-quality manner.

Recombinant Protein Expression Services

Yaohaibio has an integrated CMC development and cGMP production process platform to produce recombinant proteins, plasmids, and DNA fragments with E.coli and yeast expression systems.

Yeast expression
The recombinant protein CDMO service covers the entire life cycle of product development
Plasmid Construction
Gene synthesis
Vector construction
Strains and Strain Bank Establishment
Primary strain
Primary strain bank establishment
Secondary strain bank establishment
Process Development
Fermentation process development
Purification process development
Drug product process development
Stability Study
Specification establishment
Analytical method development
Analytical method transfer and validation
Sample Production
7-2001L fermentation production
Downstream purification process
Sterile drug product filling
Product Release
Quality control system improvement
Quality assurance system improvement
Compliance with laws and regulations
Registration Application
IND application
NDA application
International application (FDA, EMA)
Registration consultation
Commercial production
Platform Advantages
  • Integrated recombinant protein process development capability
    Comprehensive and diverse experience in recombinant protein process development, including:


    -Carrier proteins

    -Recombinant polypeptide

    -Recombinant enzymes




    Advanced process development concept
    With QbD (Quality by Design) as concept, stable and high yield process is achieved by identifying critical process parameters (CPP) based on CQA (critical quality attribute) using DoE experimental process design.

    Mature platform-based technology

    -Mature unlabeled protein process development capabilities to reduce process steps, improve protein purity, and ensure that process impurities and product impurity residues are qualified.

    -The localization of critical materials and equipment to save cost, platform-based processes to respond quickly to meet project requirements and shorten process development period.

  • Rich project experience
    Experience in recombinant protein CDMO service

    -Approval letters of over 5 IND studies

    -Successful services for over 100 recombinant protein CMC projects

    -Covering preclinical studies, clinical phase I, II and III, including several dual China-US registration projects and Australian registration projects.

    Professional Team

    -Experienced and stable CDMO service team with service experience and technical knowledge in multi-category recombinant protein projects to focus on process route innovation, quickly solve process difficulties, and reduce R&D costs.

    -Professional PM team, with excellent project management experience in the whole life cycle of biological product development, identification and management of key project paths, and identification, control and management of project risks.

  • Comprehensive production capacity

    -Large scale preparation services such as 50L-100L, 200L, 500L, 1000L and 2000L

    -2 drug product production lines (lyophilized vial/injection, pre-filled cartridges)

  • Comprehensive quality management system

    Comprehensive quality management, professional and standardized service guarantee system conforming to the latest version of Chinese Pharmacopoeia and GMP throughout the cycle to ensure continuous and stable product quality.

  • One-stop CDMO service

    One-stop service from strain construction to commercial production, covering preclinical studies, phase I, II, III clinical trials and all stages of MAH biological product production.

Recombinant protein CDMO service case
  • Interleukin expression in E.coli
  • Protein expressing in E.coli for gene editing
  • VLPs
  • Target product: Interleukin 2
    Expression system: E.coli
    Before optimization: Low expression, poor purification effect and high endotoxin content.
    After optimization through fermentation, purification, enzymatic cleavage, endotoxin removal, etc., endotoxin <1EU/mg, purity > 98%, and yield > 10 mg/g of strain.
  • Process optimization
    • Short process development cycle
    • Good process stability
    • Purity > 98%
  • Optimized process
    • Platform industrialisieren, 100% of success rate
    • Bacterial endotoxin < 1 EU/mg
    • Purity > 99%

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