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Stability of Monoclonal Antibodies as Solid Formulation for Auto-Injectors: A Pilot Study
Fatima Garcia-Villen1,2,3, Idoia Gallego1,2,3, Myriam Sainz-Ramos1,2,3
1NanoBioCel Group, Laboratory of Pharmaceutics, Faculty of Pharmacy, University of the Basque Country UPV/EHU, 01006 Vitoria-Gasteiz, Spain.
Pharmaceutics
|August 26, 2023
Summary
This study explored freeze-drying monoclonal antibodies for auto-injectors. Mannitol improved antibody stability, a key step toward better drug adherence and patient-friendly delivery systems.
Area of Science:
- Pharmaceutical Sciences
- Biotechnology
- Drug Delivery Systems
Background:
- Poor drug adherence is a major challenge in managing chronic diseases like rheumatoid and psoriatic arthritis.
- Parenteral monoclonal antibodies are effective treatments, but adherence can be limited by delivery method.
- Auto-injectors offer improved user-friendliness and reduced discomfort compared to traditional syringes, potentially enhancing adherence.
Purpose of the Study:
- To assess the feasibility of formulating a monoclonal antibody as a solid dosage form within an auto-injector.
- To evaluate the stability of the monoclonal antibody after concentration and freeze-drying.
- To screen excipients for their potential to enhance antibody stability in the solid formulation.
Main Methods:
- Concentration of monoclonal antibody solution to reduce volume.
- Freeze-drying (lyophilization) of the concentrated antibody solution.
- Differential Scanning Calorimetry (nano-DSC) to assess drug stability.
- Screening of excipients, including mannitol, for stability enhancement.
Main Results:
- Nano-DSC analysis indicated that mannitol improved the stability of the concentrated, freeze-dried monoclonal antibody.
- A slight instability in the CH2 domain of the antibody was observed even with mannitol, suggesting further research is needed.
- The results demonstrate the potential for solid antibody formulations in auto-injectors.
Conclusions:
- Mannitol is a promising excipient for stabilizing concentrated, freeze-dried monoclonal antibodies for auto-injector applications.
- Further investigation is required to fully stabilize the antibody, particularly the CH2 domain.
- This research is a foundational step towards developing advanced drug delivery systems that improve patient adherence and experience.
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