In biotechnology, excipients are substances added to a formulation alongside the active pharmaceutical ingredient (API) or biological material. Excipients serve various purposes, such as enhancing stability, improving solubility, aiding in delivery, or facilitating the manufacturing process. Excipients are inactive components that assist in the formulation, administration, or stabilization of biotechnological products, including vaccines, gene therapies, monoclonal antibodies, and other biopharmaceuticals. Some people have compared excipients to “glues.”
In biotechnology, excipients play critical roles in ensuring the safety, efficacy, and stability of the final product. For example, excipients may act as stabilizers, antioxidants, surfactants, or bulking agents to protect the biological material from degradation during processing, storage, and administration. They may also help to adjust the pH, osmolarity, or viscosity of the formulation to optimize its compatibility with biological systems or delivery methods.
Excipients in a biotech context are auxiliary substances incorporated into formulations alongside active ingredients to enhance stability, improve delivery, or facilitate manufacturing processes. These inactive components are integral to the development and production of biotechnological products, contributing to their safety, efficacy, and overall performance.