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Structure-Guided In-Use Stability Assessment of Monoclonal Antibody Tislelizumab
David Andre Rudd1,2, Ghizal Siddiqui1,3
1Drug Delivery, Disposition and Dynamics, Monash Institute of Pharmaceutical Sciences, Monash University, Parkville, VIC 3052, Australia.
Pharmaceuticals (Basel, Switzerland)
|October 29, 2025
Summary
Tislelizumab (Tevimbra), a programmed death-1 (PD-1) antibody, shows excellent stability. It maintains its structure and quality for 31 days under refrigeration, minimizing waste and ensuring therapeutic efficacy.
Area of Science:
- Biopharmaceutical stability
- Monoclonal antibody (mAb) characterization
- Immunotherapy drug development
Background:
- Monoclonal antibody (mAb) stability is crucial for clinical efficacy and waste reduction.
- Tislelizumab (Tevimbra), an IgG mAb targeting programmed death-1 (PD-1), faces potential waste due to dosing delays.
- Ensuring the in-use stability of ready-to-administer biologics is essential.
Purpose of the Study:
- To evaluate the physicochemical in-use stability of tislelizumab in a ready-to-administer format.
- To assess degradation pathways under various storage and forced degradation conditions.
- To correlate structural integrity with the mechanism of action (PD-1 blockade).
Main Methods:
- Mapping degradation pathways, including post-translational modifications (PTMs) and peptide alterations.
- Forced degradation studies (temperature, pH, oxidation, UV exposure).
- Size-exclusion chromatography (SEC) assay for aggregation and protein quantity assessment over 31 days at 2-8 °C.
Main Results:
- Aggregation was the primary degradation pathway during ultra-long-term storage.
- No measurable changes in protein quantity, aggregation, peptide integrity, or PTM profile were observed over 31 days at 2-8 °C.
- Stability was confirmed in polyolefin intravenous bags at a concentration of 1.6 mg/mL.
Conclusions:
- Tislelizumab exhibits robust structural and physicochemical stability under refrigerated conditions.
- The data support the stability of tislelizumab in a ready-to-administer format for clinical use.
- These findings contribute to minimizing drug waste and ensuring consistent therapeutic delivery.
