A Review on the Stability Challenges of Advanced Biologic Therapeutics DOI Creative Commons
Sruthi Sarvepalli,

Shashank Reddy Pasika,

Vinod Verma

et al.

Pharmaceutics, Journal Year: 2025, Volume and Issue: 17(5), P. 550 - 550

Published: April 23, 2025

Advanced biotherapeutic systems such as gene therapy, mRNA lipid nanoparticles, antibody–drug conjugates, fusion proteins, and cell therapy have proven to be promising platforms for delivering targeted biologic therapeutics. Preserving the intrinsic stability of these advanced therapeutics is essential maintain their innate structure, functionality, shelf life. Nevertheless, various challenges obstacles arise during formulation development throughout storage period due complex nature sensitivity stress factors. Key concerns include physical degradation chemical instability factors fluctuations in pH temperature, which results conformational colloidal instabilities biologics, adversely affecting quality therapeutic efficacy. This review emphasizes key issues associated with approaches identify overcome them. In brittleness viral vectors encapsulation limits stability, requiring use stabilizers, excipients, lyophilization. Keeping cells viable whole process, from culture final formulation, still a major difficulty. therapeutics, stabilization strategies optimization nucleotides compositions are used address both nanoparticles. Monoclonal antibodies colloidally conformationally unstable. Hence, buffers stabilizers useful stability. Although proteins monoclonal share structural similarities, they show similar pattern instability. Antibody–drug conjugates possess conjugation linker outlines biotherapeutics provides insights into challenges.

Language: Английский

A Review on the Stability Challenges of Advanced Biologic Therapeutics DOI Creative Commons
Sruthi Sarvepalli,

Shashank Reddy Pasika,

Vinod Verma

et al.

Pharmaceutics, Journal Year: 2025, Volume and Issue: 17(5), P. 550 - 550

Published: April 23, 2025

Advanced biotherapeutic systems such as gene therapy, mRNA lipid nanoparticles, antibody–drug conjugates, fusion proteins, and cell therapy have proven to be promising platforms for delivering targeted biologic therapeutics. Preserving the intrinsic stability of these advanced therapeutics is essential maintain their innate structure, functionality, shelf life. Nevertheless, various challenges obstacles arise during formulation development throughout storage period due complex nature sensitivity stress factors. Key concerns include physical degradation chemical instability factors fluctuations in pH temperature, which results conformational colloidal instabilities biologics, adversely affecting quality therapeutic efficacy. This review emphasizes key issues associated with approaches identify overcome them. In brittleness viral vectors encapsulation limits stability, requiring use stabilizers, excipients, lyophilization. Keeping cells viable whole process, from culture final formulation, still a major difficulty. therapeutics, stabilization strategies optimization nucleotides compositions are used address both nanoparticles. Monoclonal antibodies colloidally conformationally unstable. Hence, buffers stabilizers useful stability. Although proteins monoclonal share structural similarities, they show similar pattern instability. Antibody–drug conjugates possess conjugation linker outlines biotherapeutics provides insights into challenges.

Language: Английский

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