With the advances in medical and biotechnology research, scientists within the pharmaceutical and biotechnology industries have developed drug platforms that are able to treat complex disease and cancer at the patient level. Whether through cell and gene therapy, specialized vaccines or biologics these individual and targeted products represent the leading edge of medical science.
By definition Personalized Medicine is specific to the individual and targeted. Because of the complexity of the manufacturing process and the batch sizes being limited to only a hand-full of vials these products are of extreme value to the company producing them. Therefore, the manufacturing system to produce these products is required to maximize product yield for very small batches rather than speed. AST’s GENiSYS aseptic filling and closing system has innovative capabilities that maximize product yield and product quality.
GENiSYS aseptic filling and closing machine has an innovative dosing system that ensures that each container processed has the exact amount of drug within the container. Typically wasted product at the beginning and end of the batch can result in vials worth of wasted material. However, with AST’s in-process fill weight verification system (IPC), measurement of the material dosed into each container can be accomplished in real-time and confirmed to be correct.
To further protect the product the GENiSYS system can be integrated with an isolator-barrier system. These enclosed environments ensure that the drug is filled and closed within a contamination free area under pristine manufacturing conditions. For potent or cytoxic products the isolator will provide separation and protection to the manufacturing personnel operating the filling equipment.