Localization of pancreatic detection substrates: breakthroughs in EPS-G7 and DGGR

In the field of in vitro diagnostics, the core raw materials of pancreatic disease detection kits have long relied on imports. EPS-G7 amylase substrate and DGGR lipase substrate are key components of this detection project, and their supply stability and quality directly affect the reliability of testing in many clinical laboratories in China. In recent years, with the improvement of local enterprises' technological capabilities, these two high-end enzyme substrates are gradually being localized.

The centralized procurement policy forces the upgrading of raw materials

After multiple rounds of procurement in the field of in vitro diagnostics, the industry's focus has shifted from simple price competition to a comprehensive balance between quality and cost. The mainstream biochemical testing projects for liver function, kidney function, pancreatic function, etc. have undergone multiple price adjustments, and the industry has accumulated a market size of tens of billions of yuan and undergone redistribution. In this context, the profit margin of reagent production enterprises is compressed, while ensuring that product quality does not decline. The procurement cost and quality control of core raw materials have become key factors affecting competitiveness, providing a window for domestic high-end raw material suppliers to enter the market.

Clinical demand for pancreatic disease detection

Acute pancreatitis is a common clinical acute abdomen, and the incidence rate is on the rise. Severe patients have a dangerous course of illness, and early diagnosis is crucial for improving prognosis. The combined detection of alpha amylase and lipase is currently recognized as a routine combination for the diagnosis of pancreatitis in clinical practice. Starch enzymes rapidly increase in the early stages of the disease and are a good early screening indicator; Lipase has stronger tissue specificity, longer duration of elevation, and higher sensitivity and specificity in the diagnosis of acute pancreatitis. The combination of the two can provide valuable diagnostic information at different stages of onset.

EPS-G7 is an internationally recognized substrate for amylase detection, while DGGR is a highly specific chromogenic substrate for lipase detection. The quality of the two substrates directly affects the reliability of the detection results. If the purity of the substrate is insufficient or there are significant differences between batches, it will directly lead to deviations in the test results of the kit, which in turn will affect clinical decision-making.

Technological breakthroughs in synthetic processes

The molecular structures of EPS-G7 and DGGR are complex, with multiple synthesis steps and high purification difficulty. For a long time, there has been a lack of suppliers in China who can consistently produce high-quality products. Some early domestically produced products had issues such as high impurities and poor batch consistency, making it difficult to meet the strict requirements of clinical testing.

Hubei Xindesheng has systematically optimized the synthesis routes of EPS-G7 and DGGR based on years of technological accumulation in the field of enzyme preparations. By improving the purification method of key intermediates and the crystallization process of the final product, the content of key impurities has been effectively controlled. The purity of EPS-G7 product can reach over 98%, and the key impurity free p-nitrophenol is controlled at an extremely low level, ensuring that the background signal of the detection reaction is not interfered with. The isomer content and free chromophores of DGGR are also strictly controlled, ensuring the specificity and sensitivity of the lipase detection method.

Mass production capability and supply chain security

Realizing stable mass production at the kilogram level is the key threshold for domestic raw materials to truly enter the mainstream market. Hubei Xindesheng Material Technology Co., Ltd. has the ability to produce two substrates on a large scale, which can meet the bulk procurement needs of downstream reagent manufacturers. For reagent production enterprises, choosing validated domestic raw material suppliers can reduce procurement costs and supply chain risks while ensuring quality. With the continuous promotion of the centralized procurement policy, the importance of ensuring the safety of raw material supply will be further highlighted. If you have any recent purchasing needs, please click on the official website of Desheng to learn more details!