A Physicochemical Stability Study of Pembrolizumab Vial Leftovers: Let Us Stop Pouring Good Money Down the Drain
Background: Pembrolizumab is a monoclonal antibody (mAb) approved for treating Non-Small Cell Lung Cancer (NSCLC), melanoma and lymphomas. Commercialized in single-size (100 mg/4 mL) vials, the pembrolizumab solution contains no preservative. As such, the manufacturer recommends using pembrolizumab...
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MDPI AG
2025-02-01
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| Online Access: | https://www.mdpi.com/2226-4787/13/1/22 |
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| author | Alexandra Porlier Pierre-Yves Gagnon Valérie Chénard Marc Veillette Nicolas Bertrand Caroline Duchaine Chantale Simard Benoît Drolet |
| author_facet | Alexandra Porlier Pierre-Yves Gagnon Valérie Chénard Marc Veillette Nicolas Bertrand Caroline Duchaine Chantale Simard Benoît Drolet |
| author_sort | Alexandra Porlier |
| collection | DOAJ |
| description | Background: Pembrolizumab is a monoclonal antibody (mAb) approved for treating Non-Small Cell Lung Cancer (NSCLC), melanoma and lymphomas. Commercialized in single-size (100 mg/4 mL) vials, the pembrolizumab solution contains no preservative. As such, the manufacturer recommends using pembrolizumab vials only once, and thus, to rapidly dispose of any unused portion. Thus, appreciable amounts of this costly product are wasted. Objective: To evaluate the physical, chemical and microbiological stability of pembrolizumab vial leftovers stored at room temperature or at 4 °C, 7 and 14 days after first vial puncturing. Methods: Following pH assessments, submicronic aggregation and turbidity of pembrolizumab were measured by dynamic light scattering (DLS) and spectrophotometry, respectively. In addition, SE-HPLC (size-exclusion high-performance liquid chromatography), IEX-HPLC (ion exchange HPLC) and peptide mapping HPLC served to respectively evaluate aggregation and fragmentation, distribution of charge and primary structure of pembrolizumab. Incubation at 37 °C for 48 h of pembrolizumab vial leftovers on blood agar plates was used to determine their microbiological stability. Results: Physical, chemical and microbiological stability of pembrolizumab leftovers was demonstrated for at least two full weeks. Conclusions: These results argue forcefully in favor of allowing prolongation of pembrolizumab vial leftovers usage well beyond a single day. |
| format | Article |
| id | doaj-art-afabccb2232e41d6ba1b7cb5927cc275 |
| institution | DOAJ |
| issn | 2226-4787 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmacy |
| spelling | doaj-art-afabccb2232e41d6ba1b7cb5927cc2752025-08-20T03:12:15ZengMDPI AGPharmacy2226-47872025-02-011312210.3390/pharmacy13010022A Physicochemical Stability Study of Pembrolizumab Vial Leftovers: Let Us Stop Pouring Good Money Down the DrainAlexandra Porlier0Pierre-Yves Gagnon1Valérie Chénard2Marc Veillette3Nicolas Bertrand4Caroline Duchaine5Chantale Simard6Benoît Drolet7Research Centre, Quebec Heart & Lung Institute, Laval University, Quebec City, QC G1V 4G5, CanadaDepartment of Pharmacy, Quebec Heart & Lung Institute, Laval University, Quebec City, QC G1V 0A6, CanadaResearch Centre, CHU de Québec, Laval University, Quebec City, QC G1V 0A6, CanadaResearch Centre, Quebec Heart & Lung Institute, Laval University, Quebec City, QC G1V 4G5, CanadaResearch Centre, CHU de Québec, Laval University, Quebec City, QC G1V 0A6, CanadaResearch Centre, Quebec Heart & Lung Institute, Laval University, Quebec City, QC G1V 4G5, CanadaResearch Centre, Quebec Heart & Lung Institute, Laval University, Quebec City, QC G1V 4G5, CanadaResearch Centre, Quebec Heart & Lung Institute, Laval University, Quebec City, QC G1V 4G5, CanadaBackground: Pembrolizumab is a monoclonal antibody (mAb) approved for treating Non-Small Cell Lung Cancer (NSCLC), melanoma and lymphomas. Commercialized in single-size (100 mg/4 mL) vials, the pembrolizumab solution contains no preservative. As such, the manufacturer recommends using pembrolizumab vials only once, and thus, to rapidly dispose of any unused portion. Thus, appreciable amounts of this costly product are wasted. Objective: To evaluate the physical, chemical and microbiological stability of pembrolizumab vial leftovers stored at room temperature or at 4 °C, 7 and 14 days after first vial puncturing. Methods: Following pH assessments, submicronic aggregation and turbidity of pembrolizumab were measured by dynamic light scattering (DLS) and spectrophotometry, respectively. In addition, SE-HPLC (size-exclusion high-performance liquid chromatography), IEX-HPLC (ion exchange HPLC) and peptide mapping HPLC served to respectively evaluate aggregation and fragmentation, distribution of charge and primary structure of pembrolizumab. Incubation at 37 °C for 48 h of pembrolizumab vial leftovers on blood agar plates was used to determine their microbiological stability. Results: Physical, chemical and microbiological stability of pembrolizumab leftovers was demonstrated for at least two full weeks. Conclusions: These results argue forcefully in favor of allowing prolongation of pembrolizumab vial leftovers usage well beyond a single day.https://www.mdpi.com/2226-4787/13/1/22pembrolizumabvial leftoversstability |
| spellingShingle | Alexandra Porlier Pierre-Yves Gagnon Valérie Chénard Marc Veillette Nicolas Bertrand Caroline Duchaine Chantale Simard Benoît Drolet A Physicochemical Stability Study of Pembrolizumab Vial Leftovers: Let Us Stop Pouring Good Money Down the Drain Pharmacy pembrolizumab vial leftovers stability |
| title | A Physicochemical Stability Study of Pembrolizumab Vial Leftovers: Let Us Stop Pouring Good Money Down the Drain |
| title_full | A Physicochemical Stability Study of Pembrolizumab Vial Leftovers: Let Us Stop Pouring Good Money Down the Drain |
| title_fullStr | A Physicochemical Stability Study of Pembrolizumab Vial Leftovers: Let Us Stop Pouring Good Money Down the Drain |
| title_full_unstemmed | A Physicochemical Stability Study of Pembrolizumab Vial Leftovers: Let Us Stop Pouring Good Money Down the Drain |
| title_short | A Physicochemical Stability Study of Pembrolizumab Vial Leftovers: Let Us Stop Pouring Good Money Down the Drain |
| title_sort | physicochemical stability study of pembrolizumab vial leftovers let us stop pouring good money down the drain |
| topic | pembrolizumab vial leftovers stability |
| url | https://www.mdpi.com/2226-4787/13/1/22 |
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