Our pharmaceutical development team is highly skilled in the biologics formulation development of biopharmaceuticals including standard monoclonal antibodies, recombinant proteins, fusion proteins, antibody-drug-conjugates (ADCs) and peptides. Our experienced group includes 20 scientists (>40% with Ph.D. or M.S.) and sees continual growth to meet client demand and support ongoing expansion.
Formulation development services are available for liquid and lyophilized drug product dosage form. Our service offerings cover all biopharmaceuticals formulation development activities:
- 制剂筛选和工艺开发;
- 冻干工艺开发;
- 集装箱封闭系统选择和认证;
- 根据ICH指南进行长期和加速的药物物质和药物产品稳定性研究;
- 使用中的稳定性研究;
- 用于药品容器封盖的可萃取和可浸出测试;
- 药品制造工艺设置、设计和工艺开发;
- 临床前和临床阶段药物产品的制造;
- IND材料申请的法规支持;
- 候选物成药性评估;