To demonstrate the drug safety, we have conducted leachables study following the requirements of ICH M7, as well as USP <1663> and guidelines proposed by the PQRI working group. We established AET reflecting in worst-case of the product and SCT (Safety Concern Thresholds) value. HS-GC/MS, GC/MS, LC/MS and ICP/MS analysis were conducted depending on 4 kinds of compounds which were volatile, semi-volatile, non-volatile and element. To establish a PDE, we conducted literature review to find toxicological data following standard toxicological assessment in a manner consistent with the requirements. If experimental data for the chemical of interest or similar compounds were insufficient, an in silico (Q)SAR analysis was conducted with software validated by the U.S. FDA. As a result, it was confirmed that there is no compound above MAC (Maximum Allowable Concentration) which calculated by PDE and dose, duration, and volume of drug. We demonstrated that no safety issue was detected in leachable study of biopharmaceutical product contained in primary container.