Stabilizer Brochure

MilliporeSigma provides high-quality stabilizers and buffering agents to enhance protein stability in biologic drug formulations. Therapeutic proteins, such as monoclonal antibodies and plasma-derived products, face stability challenges due to their complex structures. These challenges include misfolding, aggregation, and loss of function caused by pH fluctuations, thermal shifts, and mechanical stress.

To combat these issues, buffering agents like phosphates, acetates, and organic buffers maintain optimal pH levels, preventing protein degradation. Stabilizing excipients such as sugars (sucrose, trehalose), sugar alcohols (sorbitol, mannitol), and amino acids (glycine, arginine) help mitigate thermal stress. Surfactants like Polysorbate 20, Polysorbate 80, and Poloxamer 188, along with cyclodextrins, prevent protein adsorption at interfaces, reducing mechanical stress-induced aggregation.

MilliporeSigma’s Emprove® Expert portfolio ensures high-purity raw materials with low endotoxin and microbial limits, critical for maintaining safety and manufacturability in injectable formulations. The company also offers specialized excipients, including nanoparticle-free sucrose and granulated glycine, to improve handling efficiency.

By selecting appropriate stabilizers and formulation strategies, protein stability is enhanced throughout the drug development process, improving therapeutic efficacy, patient safety, and manufacturing efficiency. MilliporeSigma supports risk assessment through its Emprove® Program, providing regulatory documentation and compliance support. Their portfolio enables researchers and manufacturers to develop robust, stable, and effective biologic drugs.