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4 Pharmaceutical Technology ® Trends in Formulation eBook September 2024 PharmTech.com Prioritizing Formulation Strategies for Temperature- Sensitive Biotherapeutics Feliza Mirasol Solving the challenge of better-stabilized temperature-sensitive biomolecules hinges on innovative formulation strategies. B iopharmaceutical manufacturing largely in- volves biomolecules whose stability depends on temperature. Antibodies, insulin, and, more recently, messenger RNA (mRNA)-based vaccines are examples of biotherapeutics that require cold storage. This article explores the difficulties with developing stability-enhancing formulations for tem- perature-sensitive biomolecules and technology inno- vations that are enabling their formulation. Factors that have been most challenging in devel- oping formulations that enhance stabilit y in tem- perature-sensitive biomolecules include buffer, pH, and sugar. These are usually the typical factors that need to be evaluated to thermodynamically stabilize monoclonal antibodies (mAbs), notes Joseph Cao, PhD, senior scientist, Analytical and Formulations Devel- opment, Bionova Scientific. He explains that there are different types of buffers, sugars, and a range of pH to choose from when developing a proper formu- lation for mAbs that will prevent aggregation, degra- dation (such as deamidation, oxidation), and particle formation. Besides those factors, amino acids, salts for ionic strength, and excipients are also important in developing a formulation recipe, he adds. In addition, the limited amount of therapeutic protein to work wit h poses anot her cha l lenge to formulation development. "With design of experi- ment (DoE), it has allowed us to cut the amount of protein and help us efficiently screen for factors," Cao says. "Freeze-thaw cycles, container combability, and VICTOR MOUSSA - STOCK.ADOBE.COM