PharMab, Inc., located in Zhangjiang HighTech Park of Pudong, Shanghai, China
PharMab positions itself as the leading company in China in developing biopharmaceuticals using genetic engineering techniques. Equipped with the most advanced instruments and laboratory facility, the company has established a unique technology platform stemming from numerous years of experience of its technical team in research and development of biotech products. This technology platform could streamline the production and development of therapeutic monoclonal antibody products and their derivatives.
Biotechnology will become the premier industry in the 21st century. It will be the focal point of global race in technology and economy. The bio-economy, as it builds around the biotech industry, will play the leading role in the growth of global economy in many years to come. The goal of PharMab is to become a leader China in the development of proprietary biotech products using its unique technology platform, and to compete in the international market, as China is elevating its presence and strengthen its competitiveness in the global biotech community.
Technology Platform
1. Antibody Technology Platform
With its unique and powerful techniques in immunization, fusion, and functional screening, PharMab is able to effectively develop monoclonal antibodies with high specificity and affinity against desired disease target molecules. It could subsequently humanize the antibody candidates for therapeutic development.
2. Protein Expression and Purification Platform
With its unique protein expression techniques, PharMab is able to create cell lines derived from mammalian host cells, including Chinese Hamster Ovary (CHO) and murine myeloma cells, to express the target genes at high secretion levels. Paired with its proprietary medium formulation and cell culture techniques, PharMab is also able to grow these cells in suspension culture to produce high levels of protein (including monoclonal antibody) products. In addition, PharMab also has the capability to purify these protein products to high degree of purity using chromatographic methods.
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严格贯彻“药品管理法”、"药品生产质量管理规范”、“临床药品生产质量管理规范”
1. 参与公司质量体系的建立、完善及维护质量体系；
2. 协助审核生产相关的文件，负责公司文件的复制、分发、收回和销毁等文件控制管理；
3. 负责员工培训计划、培训实施、培训汇总等工作；
4. 负责偏差、CAPA、变更、OOS等合规管理，跟踪措施的制定与实施，定期汇总。
5. 协助物料供应商管理，物料放行；
6. 对涉及产品质量活动的全过程进行有效监控；
7. 协助委托服务供应商的审计及委托生产企业的质量审计；
8. 负责公司设备管理及仪表计量；
9. 领导交给的其它任务；
