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生物藥品發展流程

Project Management*

符合國際規格的質與能

永昕cGMP生物製藥廠座落在新竹科學園區第四期竹南基地之標準廠房,佔地2,500平方米。主要設備包括Wave 200L生物反應器,各式蛋白質純化管柱,無菌充填/冷凍乾燥機,以及品管用設備等。全線使用世界最先進之拋棄式製程(Single-Use Technology),不但節省廠房、設備維護、確效、製程操作、時間之成本,在產量與專案執行上,亦展現相當大的彈性,且對於環境造成的負擔更低。

Production Process / Analytical Method Development
  • MBI’s generic platform for monoclonal antibody drugs
  • Upstream process development
  • Mammalian cell culture
  • Process development: 5 L stir tank and ambr system
  • Scale-up and GMP production: 50/200/500/2,000 L single use bioreactor
  • Microbial fermentation
  • Process development: 7.5 L stir tank
  • Scale-up and GMP production: 50 L single use bioreactor
  • Downstream process development
  • Purification process research
  • Formulation research
  • Analytical method development/qualification/validation
  • Characterization and comparability study
PIC/S GMP manufacturing
  • Master / Working cell banking
  • GMP manufacturing
  • Aseptic fill/finishing
  • Liquid in vial
  • Liquid in prefilled syringe
  • Lyophilization in vial

PIC/S GMP certificate from TFDA

cGMP certificate from TFDA
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