Evaluation of CZ-resin vials for packaging protein-based parenteral formulations

Clinical grade adult stem cell banking

“…Specifically, the Daikyo Crystal Zenith (CZ ® ) plastic vial system was investigated, which is a subject of drug package development for biologic drugs like peptides, proteins and monoclonal antibodies. [149][150][151] When DPSCs were used as a model system, our data indicated that CZ vial systems can effectively be utilized to freeze, store and ship cryopreserved DPSCs in a format that enables large scale manufacturing, and fill finish operations and in addition to care givers and patients for ease of handling and delivery.…”

Direct Visualization of Protein Adsorption to Primary Containers by Gold Nanoparticles

“…Previous studies showed that CZ R plastic vials bound less protein at low concentration (∼10 :g/mL) compared with glass. 24 CZ R plastic vial can be a viable alternative to glass-based primary containers to minimize adsorption of proteins to containers. Previous studies suggested that electrostatic interactions between protein and glass is the major force responsible for adsorption of proteins to glass and may involve the binding between negatively charged dissociated silanol groups on glass surface and positively charged amine groups from proteins.…”

Packaging Considerations for Biopreservation

“…The CellSeal vial body is constructed from a commercially available cyclic olefin co-polymer (COC) (TOPAS ® COC; TOPAS Advanced Polymers GmbH, Frankfurt/M., Germany). COC resins are currently being used to package and deliver pharmaceutical drugs worldwide [10][11][12]. With a variable glass transition temperature from 70 °C up to 177 °C [13], COC is more break resistant at cryopreservation storage temperatures which helps reduce sample loss during filling, freezing, storage, shipping and retrieval.…”