ArticlePharmacy (Basel, Switzerland)2025
A Physicochemical Stability Study of Pembrolizumab Vial Leftovers: Let Us Stop Pouring Good Money Down the Drain.
Article in Pharmacy (Basel, Switzerland), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
8 authors.
Funding
Abstract
backgroundPembrolizumab 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.
objectiveTo 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.
methodsFollowing 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.
resultsPhysical, chemical and microbiological stability of pembrolizumab leftovers was demonstrated for at least two full weeks.
conclusionsThese results argue forcefully in favor of allowing prolongation of pembrolizumab vial leftovers usage well beyond a single day.
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