Enzymes, as natural biocatalysts, have been widely used in various fields such as industrial manufacturing, in vitro diagnostics, and pharmaceutical research and development. Although their essence is protein, there are significant differences in purity, activity, specificity, and production processes among enzyme preparations used for different purposes under the general term "enzyme". More importantly, its storage and usage conditions also vary depending on the application scenario. Understanding the differences between industrial enzymes, detection enzymes, and pharmaceutical enzymes not only helps with rational selection, but also ensures their effectiveness in practical applications.

enzyme preparations 

Industrial enzymes: pursuing cost-effectiveness and environmental tolerance

Industrial enzymes are widely used in food processing (such as amylase and protease), textiles (such as cellulase), detergents (such as lipase), biofuels (such as cellulase), and other fields. The core requirements for this type of enzyme are high catalytic efficiency, strong environmental adaptability, and low cost.

Industrial enzymes usually have relatively low purity requirements, allowing for the presence of small amounts of impurities as long as they do not affect the overall reaction efficiency. Its production often adopts large-scale fermentation, focusing on yield and economy. For example, high-temperature resistant alpha amylase can continue to function above 90 ℃ and adapt to industrial high-temperature processes; Alkaline protease can maintain activity in strongly alkaline environments and is suitable for laundry detergent formulations.

Testing enzymes: emphasizing high purity, high specificity, and batch consistency

Enzyme detection is mainly used for in vitro diagnostic kits, such as enzymatic determination of blood glucose, uric acid, ALT, CK-MB and other items. The core requirements for this type of enzyme are high specific activity, high purity, low non-specific reactions, good batch stability, and catalytic ability at physiological temperature (37 ℃).

Taking lactate dehydrogenase (LDH), uricase, glucose oxidase, and other impurities as examples, their proteins may interfere with the reaction system, leading to increased background signals or false positive results. Therefore, enzymes used for detection usually need to undergo multi-step chromatography purification to ensure purity ≥ 90%, and undergo strict quality inspections such as activity, specificity, and stability.

Drug enzymes: safety and clinical compliance as the core

Drug enzymes are directly used for human treatment, such as thrombolytic enzymes (urokinase, streptokinase), digestive enzymes (trypsin), anti-tumor enzymes (L-asparaginase), etc., which belong to the category of drugs and have relatively strict requirements.

Drug enzymes not only require high purity and activity, but also need to pass safety tests such as sterility, non pyrogen, low immunogenicity, and comply with GMP production standards and clinical registration requirements. Strict control of host protein residues, DNA residues, and virus inactivation processes is required during the production process to ensure the safety and effectiveness of clinical use.

Conclusion: Only by selecting the right enzyme can we use the right field

Although industrial, testing, and pharmaceutical enzymes belong to the same enzyme class, they have completely different quality standards, application scenarios, and storage requirements. Confused use may lead to risks such as inaccurate detection and process failure. Hubei Xindesheng is deeply engaged in the field of in vitro diagnostics, focusing on the research and production of high-purity and highly active detection enzymes. The company's products include various core enzyme preparations such as lactate dehydrogenase (L-LDH), creatine kinase (CK-MB), uricase, glucose oxidase, etc., all of which use genetic engineering expression and multi-stage purification processes to ensure high specificity, low impurities, and batch stability.