Novel Plastic Bag for Monoclonal Antibody Final Bulk Storage to Actively Prevent Oxidation

Essentially, human protein such as monoclonal antibody is quite susceptible against oxidation. Nevertheless using the oxygen barrier containers, oxygen within the protein solution and oxygen leaking through the closure port of container affect to the protein. To minimize oxidation of monoclonal antibody, novel plastic bag for monoclonal antibody final bulk storage has been developed. The concept “Active” means that removing oxygen not only passively from the circumstances through the barrier layer within the container (or bag), but also actively removing oxygen both from the closure port of container (or bag) and from the inside of monoclonal antibody final bulk solution. As the materials used are mainly polyethylene without additives, it withstands to very cold storage temperature, such as -80 degree Celcius, and it shows quite low extractables performances. Its safety will be demonstrated under the condition of USP, JP and EP.