主催: 日本臨床薬理学会
会議名: 第43回日本臨床薬理学会学術総会
回次: 43
開催地: 横浜
開催日: 2022/11/30 - 2022/12/03
PURPOSE
The dosage of the CTLA-4 blocker ipilimumab is based on patient's body weight, often resulting in leftover drug after sterile compounding. This study sought to assess the long-term stability and quality of leftover ipilimumab within vials, to facilitate drug vial optimization (DVO) using a closed-system transfer device for cost savings.
METHODS
Used vials for intravenous infusion of ipilimumab at Sapporo Medical University Hospital were collected after preparations. Each vial was sealed and stored with protection against light at 4℃. A small amount of the remaining drug solution was withdrawn from the vials at each week over the course of an 8-week study period. Stability assessment was performed in terms of IgG concentration and binding activity to CTLA-4. In addition, sub-visible particles of leftover ipilimumab within the vials were characterized by nanoparticle tracking analysis with the NanoSight NS300.
RESULTS
The IgG concentrations of ipilimumab remaining within vials, as well as binding activity to CTLA-4 protein, did not change significantly over 8 weeks of storage at 4℃. Furthermore, the size distribution profiles of submicron particles ware comparable at each week with the median mode diameter of 88 nm (range, 84-97 nm).
CONCLUSION
Although the smaller 20 mg vials have been available in Japan to reduce leftover ipilimumab waste, 50 mg and 200 mg vials are still distributed in US and Europe. Our results suggested long-term stability and quality of leftover ipilimumab within the vials, which should contribute to implementation of DVO for cost savings.