不良事件/反應(yīng)報(bào)告
https://www.walvax.com/public_information/?type=5&id=1
不良事件/反應(yīng)報(bào)告
Production System and Quality Management
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So far, our pilot workshop has successfully produced its own bivalent HPV vaccine (Walrinvax®) and nine-valent HPV vaccine samples for IND application and clinical trials. Meanwhile, it also has provided outsourcing services for several biopharmaceutical companies for IND filings from Phase I through Phase III clinical trials.
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Pilot Plant
Zerun Biotech has more than 1000 m² GMP-compliant pilot production workshop in Shanghai Zhangjiang Pharmaceutical Valley, equipped with various high-end equipment and facilities, such as 30~200 L stainless steel fermentation tank, 50~200 L disposable bioreactor, 50~450 mm chromatography scale purification system, 1800 pcs/hour scale filling line (vial & pre-Fill-Seal), 1 m²scale vacuum lyophilization system, etc. It can satisfy the production and research of clinical trial samples of recombinant protein drugs with yeast or mammalian cells as carriers.
Yuxi Zerun Biotechnology Co., Ltd.（Yuxi Zerun）
A wholly-owned subsidiary of Shanghai Zerun
Quality Management
Zerun regards quality as the life and soul of its products, adheres to the corporate culture of quality first, and ensures the effective operation and continuous improvement of the quality system throughout the whole process of R&D and production, so as to provide the public with reliable and high-quality vaccines. The company has established a comprehensive quality management system that covers the life cycle from research and development to manufacturing after launch, and will be able to meet the requirements of both NMPA (National Medical Products Administration) and WHO for pre-certification after the products are industrialized.
R&D Quality system：
The R&D Quality system ensures that procedures are standardized and processes are clearly defined. Straight forward quality control plans improve R&D efficiency on the basis of compliance and gain more time for innovation rather than procedures that stifle creative ideas. Reinforce the concept of quality from design, strictly follow GXP, and ensure the truthfulness, accuracy and integrity of data.
Manufacturing quality system：
The management of the production quality management system is based on domestic (NMPA) and international standards (ICH, WHO, MHRA and USFDA) to form an organic whole of quality management with clear responsibilities, mutual coordination and mutual promotion. Relying on a fine document management system, based on the management of risk, knowledge, verification, etc. to ensure the effective operation of the entire quality system and then to ensure product safety and effectiveness.
WHO Prequalification：
With the goal of entering the international market, Zerun Biotech is actively promoting the internationalization of its products and gaining access to the bulk procurement opportunities of international organizations. To achieve this goal, the company has set up a WHO PQ team to ensure that every aspect of plant design and product manufacture meets WHO standards，ensuring that Zerun Biotech produces high quality, safe and effective vaccine products and obtains international recognition.
Zerun Biotech regards quality as its life and soul, aiming to provide the public with reliable and high-quality vaccines. We are committed to:
- Adhere to the corporate culture of quality first
- Integrate quality awareness throughout our R&D and production process
- Ensure the effective operation and continuous improvement of quality system
- Manufacture safe and effective vaccine products
