生物相似性藥品開發 & CDMO

Biosimilar Development & CDMO
CDMO的委託開發及生產服務,含細胞株開發、製程開發與放大、分析方法開發與確效、產品鑑定、臨床試驗用GMP生產與安定性試驗,以及CMC化學製造管制。生物相似藥開發以逆向工程技術為核心,其中EG12014全球臨床試驗已於2021的3月完成,分析結果達到生物相等性標準。
The commissioned development and production services of CDMO include cell line development, process development and amplification, development and validation of analytical methodology, product identification, GMP production and stability tests for clinical trials, and CMC (chemical, manufacturing, and control). The development of biosimilars is based on reverse engineering technology. Among the products, EG12014 completed its global clinical test in March 2021, and the analysis results reached the bioequivalence standard.