HJB’s GMP manufacturing site is going to have its own BOSCH Isolated Vial Drug Product Filling line in the year of 2020 which is applicable for 2-50 mL vials (Refer to pictures below). The designed filling capacity will be 200 vials per minute (5 mL filling volume for example). This isolator Drug Product Filling line will be ready for GMP aseptic fill finish in Q1 2021. Based on the designed production system, all parts in direct contact with products are disposable, which prevents cross contamination and ensures product safety.
Before the in-house Drug Product Filling line is ready, all internal and external projects GMP drug product fill finish are outsourced to Sichuan Kindos Pharmaceutical Company which has been inspected and approved multiple times by U.S. FDA with ZERO observation. Project leader will be fully engaged the drug product production activities and be 100% on-site supervision. Multiple projects have been successfully filled at Kindos. As per business risk management, we have also business cooperation with other high quality Drug Product CMOs as backup.