Freeze-drying or lyophilisation is a technique commonly used for pharmaceutical products, in which stability is required to be preserved beyond 4°C temperature. Although lyophilisation is a well‐established method, designing a sustainable process for a new product is still to a large extent subjected to empirical practice and often requires trial and error approach. Moreover, even successful lyophilisation of the product may not assure its good long‐term storage stability, and progressive decrease in activity may still be encountered. In the past decades, numerous studies have been conducted in the area of protein instability and preservation during lyophilisation and long‐term storage. Many critical issues have been identified with regard to physical and chemical instability of proteins in the solid.
Part of the book: Sustainable Drying Technologies