All materials used in the manufacturing process are controlled via specifications and sourced from qualified suppliers. This includes: 
- Cell Banks: A two-tiered system of a Master Cell Bank (MCB) and a Working Cell Bank (WCB) of HEK293 cells is used. The MCB has been extensively characterized for identity, purity, and adventitious agents. 
- Plasmids: The three plasmids used for transfection are manufactured under cGMP conditions and are controlled by specifications for identity, purity, and concentration.
- Cell Culture Media & Reagents: All media, sera, and critical reagents are subject to release testing and are certified free of adventitious agents.