Developability and formulation screening platform
China leading formulation development platform supports developability study for higher survival rate,; DoE based formulation screening to identify traditional or innovative formulation candidates for either regular mAb or protein molecules (such as fusion proteins/enzymes) with unique stability challenges; Formulation confirmation and long term stability studies.
Highly integrate Drug Product development platform also supports studies such as force degradation, container/closure (CCS) screening and integrity test and clinical in-use study.
Development platform for aseptic liquid filling and lyophilization process
QbD based filling PD. Use scale-down model in every step (freeze/thaw, pool/mixing, aseptic filter, filling) to sufficiently understand production process (CPPs and AORs), and guide subsequent GMP scale up and tech transfer to insure success.
Advanced lyophilization PD, including determination of excipients, Tg and Tc determination, lyo product physicochemical property determination, container/stopper selection and lyo cycle development, in order to support the formulation development of unstable molecule in liquid.
Non-GMP / GMP Pilot Aseptic Liquid Filling / Lyophilization Production Platform
Aseptic liquid filling/Lyophilization production line with advanced washing, depyrogenation, filling and capping assembly functions. Supports pilot scale production of small volume parenteral (SVP) (including lyophilized products) in broad range of vial formats. Pre-filled syringe fill/finish production line is under construction.
Aseptic liquid Filling / Lyophilization Production Platform supports the development and validation of processes in the freeze and thaw, buffer preparation, sterile filtration ,filling, lyophilization, stoppering and capping for biologics. Advanced environmental monitoring system ensures the pilot production for various types of biologics under cGMP conditions.