Formulation and Filling
Biopharmaceutical filling processes operate under rigorous aseptic criteria. Aseptic processing describes the final stage of manufacturing, wherein a sterile (aseptic) product is packaged in a sterile container in a clean, controlled environment using methods and technologies that maintain sterility. Product containers are filled and sealed under high-quality environmental conditions designed to minimize contamination.
CinnaGen Co has a full state-of-the-art fill and finish facility, located in three different buildings. We also have almost 10 years of experience with aseptic filling and lyophilization of drug products and excessive experience in filling a wide variety of biotherapeutics. The dedicated filling lines of CinaGen Co. that we can offer is as follows:
- One vial+ one PFS(Prefilled syringes) line in SD1
- One vial+ one PFS(Prefilled syringes) line in SD2
- A cartridge filling line which enables us to produce our drug products as pen in SD4
- (Totally resulting 5 aseptic filling suites)
- Flexible filling volumes between 0.5 mL to 50 ml for vials, 0.5 mL to 1.5 ml for syringes, and 0.5 to 3 ml for cartridges
- Almost fully automated filling machines
- Lot sizes ranging from 1,000 to 75,000
Also we are equipped with two different freeze dryer machines with different capacities. The process of freeze drying can achieve product stability, and improved shelf-life. CinnaGen Co. can provide lyophilization cycle development and optimization services at both clinical and commercial scale.
/ Formulation and Filling Department /