Enzyme Preservation Magic – Decoding the Development of Enzyme Lyophilization Technology

Challenges of Enzyme Lyophilization: How to Lock in 100% Activity

Biological products such as proteins, enzymes, and antibodies are prone to physical degradation (e.g., denaturation, aggregation) and chemical reactions (e.g., oxidation, hydrolysis) when in solution, leading to instability in their structure and function [1]. With the rapid development of biotechnology, many biological products have begun to adopt lyophilization technology to extend their shelf life and improve transportation convenience. This method removes moisture from the substance by directly sublimating it from the solid state to the gaseous state, thereby preserving the original biological activity of the sample without damaging its structure, achieving long-term stable storage. However, during the actual lyophilization process, for biological active molecules such as enzymes that are extremely sensitive to environmental conditions, they may be affected by various adverse factors, including low-temperature stress [2], concentration effects [3], changes in pH value [4], phase separation [5], and dehydration stress, causing reversible or irreversible changes in the protein structure, thereby affecting activity. Ensuring the effective retention of enzyme activity before and after lyophilization has become an urgent technical problem that needs to be solved. In addition, even under ideal storage conditions, enzyme preparations still face the risk of gradually losing activity during storage, affecting the product's final effect and increasing production costs.

 

Key Factors Affecting the Activity and Stability of Enzyme Lyophilization

Key Parameters of Lyophilization Process: Unlocking the Best Path

Lyophilization mainly includes key stages such as pre-freezing, annealing, primary drying, and secondary drying. Precise control of the conditions and parameters of each step is crucial for ensuring the biological activity and stability of enzyme preparations after lyophilization, among which the freezing temperature in the pre-freezing stage, the collapse temperature and heating rate in the primary drying stage, and the temperature and time in the secondary drying stage are particularly important.