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
Productionof various specifications of drug substance at different scales (50L-100L, 200L, 500L, 1000L and 2000L)
Comprehensive and complete technology transfer process and risk control system
Comply with NMPA, FDA, and EMA requirements, comprehensive quality management system, experienced quality management team
Over 80% of production line is under intelligent operation
TEL: +86-523-86285566
Address: Building 29, No. 801, Jiankang Avenue, Taizhou, Jiangsu
Email: BD@yaohaibio.cn
Copyright © Yaohaibio - All Rights Reserved Web design
Privacy policy | Terms & Conditions | Modern Slavery Act Statement | Sitemap