制剂产品开发主要是按美国FDA的要求研发出工艺简洁、稳定,质量与原厂产品一致的制剂药品。在制剂研发过程中会根据原料药的理化性质合理地选用辅料,根据药品特性设计和优化处方,开发出质量稳定、药品特性与原厂产品一致、符合FDA要求的产品。在工艺开发工作中会考虑可放大性和稳定的生产能力,开发出低成本、低能耗、操作简单的工艺过程以满足将来商业化生产的需求。同时需要组织整理制剂及工艺的相关申报文件协助产品的申报。在商业化生产前协助生产部门进行产品工艺验证以保证工艺及产品质量的稳定性。

Formulation development focuses on the development of stable and good quality product for US market. According to the physicochemical properties of drug substance, reasonable formulation and process are designed. QbD and DoE are applied to the product development work to make quality product which is consistent with reference brand product on US market to meet FDA requirements. In process development, we target to develop scalable, low cost, energy efficient, and robust process which will meet the future product commercialization requirements. We also collect CMC documents for client for regulatory filing. Prior to product commercialization, we also provide assistance in process validation performed by customer's production site to ensure the robust manufacturing process to produce quality product consistently.

 
   
  自主研发普通药物流程  
     
   
  与国外厂商合作研发创新药