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Drug Substance Production
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Drug Substance Production Service
With one-stop contract production capability, Yaohaibio provides production services for preclinical, clinical and marketed drugs. Currently, 5 drug substance production lines have been established based on the concept of Quality by Design (QbD) in accordance with GMP of NMPA, FDA, and EMA, providing diverse scales of bioreactor of 50 L-100L, 200 L, 500 L, 1000L, and 2000 L. On the back of international advanced equipment, flexible production line configuration, and the highest standard quality system, we promote new drug development progress efficiently.
Services
  • Strain Bank Establishment within GMP system
  • Pilot-scale Process Optimization, Scale-up and Production
  • Production of Sample Preparation Batch for IND Registration Application
  • Production of Samples for Phase I-III Clinical Trial
  • MAH Industrialized Production
  • Standards Preparation
GMP drug substance production with high productivity and high flexibility

Drug substance production area over 10,000㎡ conforming to GMP

Multi-scale (50L-100L, 200L, 500L, 1000L and 2000L ) fermentation service platform conforming to GMP

Independent upstream and downstream production areas, equipped with fully functional process equipment

Upstream: 5 drug substance production lines, with the production capacity of 7500L, fermentation equipment of various specifications

Downstream: 5 purification production lines, equipped with various chromatography and ultrafiltration systems, with wide process coverage

Reasonable plant design, D/I/O/PQ-verified air-conditioning and water system, etc. and GMP-satisfied production workshop.

I/O/PQ-verified domestic high-quality equipment (partially imported) with provided PQ report. The instruments are fully calibrated

compliance QA, operational QA and validation teams in place to ensure the efficient implementation of the quality system

Service Capability
  • Commercial Scale

    Productionof various specifications of drug substance at different scales (50L-100L, 200L, 500L, 1000L and 2000L)

  • Abundant experience in technology transfer

    Comprehensive and complete technology transfer process and risk control system

  • Compliance Assurance

    Comply with NMPA, FDA, and EMA requirements, comprehensive quality management system, experienced quality management team

  • Powerful Data Management

    Over 80% of production line is under intelligent operation

Focus on
microbial expression system
CDMO service leader

CONTCT US

TEL: +86-523-86285566

Address: Building 29, No. 801, Jiankang Avenue, Taizhou, Jiangsu

Email: BD@yaohaibio.cn

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