The Role of Carbohydrates: A Key Class of Biologic Excipients
Carbohydrate-based excipients are a foundational class of ingredients in the biopharmaceutical industry, playing a vital role in the formulation of many biologic drugs. These excipients, which include sugars like sucrose and trehalose, are highly valued for their ability to act as stabilizers and cryoprotectants. Their primary function is to protect sensitive biological molecules, such as proteins and antibodies, from degradation during processes like freeze-drying and long-term storage.
Carbohydrates achieve this stabilization by creating a protective environment around the protein, preventing it from unfolding or aggregating. In lyophilized (freeze-dried) formulations, for example, high-purity disaccharides are used to maintain the integrity of the solid form and protect the drug from the stresses of freezing and dryness. They help to maintain the protein's native structure, ensuring the drug remains potent and effective over time.
Beyond stabilization, carbohydrates also function as bulking agents, which are essential for creating a uniform and sturdy freeze-dried cake. This is particularly important for small-dose formulations where a bulking agent is needed to create a manageable product. Their multifaceted roles make carbohydrate-based excipients an indispensable component in the development and manufacturing of a wide range of biopharmaceuticals.
FAQs
What is the main function of carbohydrate excipients? Their main function is to stabilize sensitive biologic molecules and protect them from degradation during manufacturing and storage.
Are all carbohydrates suitable for biologic formulations? No, certain reducing sugars are often avoided in formulations as they can react with proteins and cause deactivation over time.