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R&D system
Relying on the technical platform of the parent company Yaohai Bio

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

Recombinant proteins have been widely used in the fields of 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 directions such as antibody drug target screening, CAR-T cell therapy, CDC conjugate drugs, enzyme preparations, influenza virus proteins and cytokines.





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


Yaohai Bio is committed to developing a recombinant protein CDMO service platform with robust processes, which can provide customers with full life cycle services from genetic engineering bacteria construction, strain library establishment, small-scale process development/optimization, pilot process amplification, IND application and clinical sample preparation, quality standard establishment, analytical method development/validation, quality management system establishment, NDA registration application and commercial production (MAH), to meet customers' commercial needs at different stages of recombinant protein drug product development. With rich experience in process development and production, we are committed to providing fast and high-quality services to customers' project entrustment.

The technological platform advantages of parent company Yaohai Biotechnology
  • Integrated recombinant protein process development capabilities

    We have comprehensive and diversified experience in recombinant protein process development, including:

    -Cytokines

    -Carrier proteins

    -Recombinant polypeptides

    -Recombinant enzymes

    -Allergens

    -VLPs

    -Vaccines


    Advanced process development concepts

    Based on the requirements of the Quality by Design (QbD) concept, through DoE experimental process design, with CQA (critical quality atttibute) as the starting point, we confirm the critical process parameters (CPP) to achieve a stable process with high yield and high yield.


    Mature platform technology

    -Mature label-free protein process development capabilities, reducing process steps, improving protein purity, and ensuring that process impurities and product impurity residues are qualified.

    -Realize the localization of key materials and equipment, save costs, and platform technology can quickly respond to project needs and shorten process development time.

  • Rich project experience
    Experience in multiple projects of recombinant protein CDMO services:
    ->5 IND clinical approvals
    ->100 successfully served recombinant protein CMC projects
    -Covering preclinical research, clinical phase I, II and III clinical trials, including multiple Sino-US dual-application and Australian registration projects

    Professional team guarantee
    -Matching an experienced and stable CDMO service team, with multi-category recombinant protein project service experience and technical accumulation, focusing on process route innovation, quickly solving process difficulties, and reducing R&D costs.
    -Professional PM project management team, with superb mastery of the full life cycle project management experience of biological product development, identification and management of project critical paths, identification, control and management of project risks.
  • Comprehensive production capacity guarantee
    - Large-scale preparation services such as 50L-100L, 200L, 500L, 1000L and 2000L
    - 2 preparation production lines (lyophilized vials/water injections, prefilled cartridges)
  • Complete quality management system
    We can provide comprehensive quality management, have a professional and standardized service guarantee system, comply with the new edition of the Pharmacopoeia and GMP-related guidelines throughout the entire cycle, and provide customers with sustained and stable product quality.
  • One-stop CDMO service
    We can provide customers with one-stop services from strain construction to commercial production, covering all stages of preclinical, clinical phase I, II, III and MAH biological product production.

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