研发与技术页面-质量与生产-Quality management
Quality management
Dongfang Baitai regards drug quality as the life of the enterprise. All staff keep quality in mind. The company takes "pharmaceutical innovation, scientific integrity, the pursuit of excellence, continuous improvement" as the drug quality guideline. We adhere to the concept of quality by design (QbD), take safety, effectiveness and stability as the production standard, and follow the GMP management standard of China, EU and FDA. Dongfang Baitai has passed the ISO9000 quality management system. It is in line with international advanced standards. In addition, the high standard dynamic management of drug quality risk is carried out in all aspects.
Eastern Biotech based on the pharmaceutical industry. The company implements national laws and regulations and continuously improves quality management methods. The company has set up a "quality management center" to independently perform the sacred duties entrusted by the Drug Administration Law and the Drug Manufacturing Quality Management Practice (GMP) to ensure the safety and effectiveness of the drugs produced. At the same time, it ensures the compliance of the whole process from new molecule discovery, pharmacological and toxicological research, process development, clinical research to production.
NMPA management specification
The company strictly abides by the laws, regulations and standards of the National Medical Products Administration.
GMP management practice
The company strictly follows the basic principles and requirements of drug production quality management standards to ensure drug quality.
ICH, FDA regulations
The company follows the requirements of ICH, FDA and other international pharmaceutical industry regulatory guidelines.
QBD concept
The company analyzes the key quality attributes of products and confirms the key process parameters to ensure stable production process and controllable product quality.
Quality management system
The company has established a quality management system covering the whole life cycle of products based on risk management, focusing on prevention and continuous improvement.
Quality Control laboratory
The company strengthened product quality control and characterization. We fully understand the quality characteristics of each product to provide guidance for product development and production.
Quality and Production Quality and Production
With the international advanced level as the standard, the company has built a 3*2000L large-scale batch culture and purification production line of mammalian cells as well as a supporting R & D and quality control laboratory. It covers research and development industrial facilities such as different types of preparation production lines, pilot production lines and so on, such as liquid filling dosage forms, pre-filling and card type bottles.
The antibody drug research and development and industrialization (Phase I) project under construction by Dongfang Baitai has a total construction area of 40,000 square meters. It will officially enter service in 2023. It is a world-class comprehensive antibody drug research and development and industrialization base. It includes a complete technology platform system including antibody drug discovery, pilot trial, large-scale production and quality research. The platform system can provide innovative research on multiple antibody drugs and achieve industrialization transformation.
Production & OperationThe production operation
Biological products industrial production workshop
The biological products production workshop under construction of Eastern Biotech has a purification area of 4,000 square meters, which is divided into cell culture production area, protein purification production area and preparation filling production area.
Cell culture production area
The equipment in this area includes 3*2000L multiple sets of stainless steel bioreactor. There are multiple sets of disposable bioreactors with different specifications and corresponding solutions. The medium preparation system can meet the requirements of cell culture in different projects.
Protein purification production area
The production equipment in this area includes several sets of Cytiva AKTA process purification equipment, stainless steel solution preparation tank and disposable liquid distribution system, automatic ultrafiltration system, virus removal filtration system and other equipment.
Preparation filling production area
The production equipment in this area includes Star Coxillin bottle and canning production line (300 bottles/min), pre-sealed syringe and pre-sealed card-type bottle 2-in-1 canning production line (280 bottles/min), as well as supporting disposable liquid dispensing system, semi-finished product dilute dispensing system, etc.
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Address: No. 2, Rongjing East Street, Beijing Economic and Technological Development Zone
Tel.: 010-51571019
Email: ebt@east-bt.com
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