ALBAN Biologics Contract manufacturing site is a leader and the largest developer and manufacturer in China for Biologics with cFDA-GMP Approval, QP Declaration since 2001 and FDA approval inspection planned. It operates the largest and most sophisticated antibody production facility in China with Western technologies in a total of over 38,000-liter mammalian cell culture capacity. As the facility approved by Columbia/Mexico/Ukraine/Brazil, there are serval drug products manufactured at the site to supply many countries in the world.
The site is equipped with a cutting-edge in house R&D engine for cell line, process and formulation development, fill & finish and analytics
- Four Independent production line of total 38,000L
- State-of the art stainless steel bioreactors and centrifuges
- Chromatography columns up to 1.4m in diameter
- Dedicated bulk fill suite
- Full integrated process equipment from vail washing to capping
- All critical process performance to prevent product contamination through RABS
- Aseptic filling including Lyo vial and Liquid vial with fully automated loading / unloading system
- Full automated clean in place (CIP) and sterilization in place (SIP)
- Continuous centrifugation and disposable depth filtration
- Highly automated operation to minimize product contamination.
- Classified Manufacturing Site with Grade A, B, C and D controls
- Fully Temperature Controlled Warehouse with 25,000 square meters
- Suitable for Vials and Pre-filled syringes (PFS)