Our filling line and lyophilization line, also designed in compliance with the requirements of FDA, EMA, and NMPA, enable aseptic production of high-quality drug products for clinical trials and commercial use.
Notably, the critical areas of the filling line achieve Class A cleanliness with laminar airflow system, and the surrounding areas, including the non-critical areas of capping (Class C cleanliness) and filling (Class B cleanliness), vial washing area (Class C cleanliness), and instrument sterilization area (Class C cleanliness), also provide environmental assurance for a successful production.
With our strong GMP-compliant capability in R&D and DS and DP manufacture, and sophisticated GMP management and manufacture experiences, we are competent to fast track our products from R&D to BLA, maximally reduce the risks and costs from process and manufacture site changes, and make our products more commercially competitive.