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1. Introduction
Sucrose – a widely used stabilizing excipient for proteins, monoclonal antibodies (mAbs), recombinant enzymes, and vaccines.
2. Key Advantages
Protein & Antibody Stabilizer: Maintains tertiary and quaternary protein structure, preventing denaturation and loss of activity.
Effective Cryo-/Lyoprotectant: Protects biomolecules during freezing and lyophilization, forming a stable glassy matrix.
Long-term Stability: Reduces risks of hydrolysis, aggregation, and oxidation.
Safe & Regulatory Accepted (GRAS): Recognized by FDA & EMA, extensively used in pharmaceuticals and biologics.
Cost-Effective: An economical alternative compared to other high-performance stabilizers (trehalose, mannitol).
3. Product & Manufacturer
Sucrose Pharmaceutical Grade – compliant with Ph. Eur, USP, JP
Manufactured under GMP / EXCiPACT standards
High-purity white crystalline powder, easily soluble, suitable for biologics production
5. Commercial Products using Sucrose:
This highlights the essential role of sucrose in the next generation of biologic formulations.
This post is prepared by Nhon
