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Published on: November 5, 2016
Stability study of full-length antibody (anti-TNF alpha) loaded PLGA microspheres
S Marquette1, C Peerboom2, A Yates2
1Laboratory of Pharmaceutics and Biopharmaceutics, Université Libre de Bruxelles (ULB), Campus de la Plaine, CP 207, Boulevard du Triomphe, Brussels 1050, Belgium; Laboratory UCB Pharma S.A., Chemin du Foriest, Braine-L'Alleud 1420, Belgium.
Antibody-loaded PLGA microspheres require cold storage for stability. Resomer® RG755S polymer is best for maintaining antibody integrity and controlled release, preventing degradation and activity loss.
Area of Science:
- Pharmaceutical Sciences
- Biotechnology
- Materials Science
Background:
- Antibodies (Abs) are susceptible to degradation, necessitating stable formulations and delivery systems.
- Controlled-release strategies are crucial for therapeutic antibody efficacy.
- Polylactide-co-glycolide (PLGA) microspheres offer a promising platform for antibody encapsulation.
Purpose of the Study:
- To encapsulate an anti-TNF alpha monoclonal antibody (MAb) into PLGA microspheres for controlled release.
- To evaluate the stability of MAb-loaded PLGA microspheres under various storage conditions.
- To identify optimal PLGA polymer composition and storage temperature for MAb stability.
Main Methods:
- Solid-in-oil-in-water (s/o/w) emulsion method for microsphere preparation.
- Encapsulation of spray-dried anti-TNF alpha MAb microparticles into PLGA microspheres using Resomer® RG505 and Resomer® RG755S.
- Stability assessment of MAb-loaded microspheres at 5°C, 25°C/60% RH, and 40°C/75% RH for 12 weeks.
Main Results:
- MAb-loaded PLGA microspheres demonstrated stability only when stored at 5°C.
- Resomer® RG755S (75% lactic acid PLGA) was superior in preserving MAb stability compared to Resomer® RG505.
- Elevated storage temperatures induced antibody aggregation, fragmentation, loss of activity, and altered release profiles.
- Physical aging of microspheres was observed, indicated by changes in glass transition temperature and enthalpy of relaxation.
Conclusions:
- Cold storage (5°C) is essential for maintaining the stability and activity of MAb-loaded PLGA microspheres.
- PLGA microspheres formulated with Resomer® RG755S provide a more stable system for antibody encapsulation.
- Understanding physical aging is critical for predicting the long-term performance of antibody-loaded PLGA delivery systems.
