Introduction

In the field of in vitro diagnostics (IVD), chemiluminescent immunoassay has become a mainstream detection technology due to its high sensitivity and high level of automation. The performance of such systems relies heavily on the quality of core raw materials, especially labeling enzymes. Alkaline phosphatase (ALP), which catalyzes reactions without the involvement of hydrogen peroxide or metal ions, produces low background noise and a stable “glow-type” signal, has therefore become a key enzyme label widely used in high-end chemiluminescent systems.

Addressing the Pain Points: Import Dependence and the Technological Breakthrough of Domestic ALP

For a long time, the market for high-performance ALP raw materials has been dominated by a small number of international suppliers. This has left the domestic IVD industry facing challenges such as long procurement cycles, insufficient supply chain stability, dependence on external parties for core costs, and limited flexibility for in-depth customized development. Such reliance not only affects economic efficiency, but also poses potential risks to industrial chain security and technological autonomy.

As a leading domestic raw material manufacturer, Hzymes has concentrated its R&D strengths and leveraged advanced technologies including recombinant gene expression, protein-directed evolution, and glycosylation modification optimization. Through these efforts, Hzymes has achieved substantial breakthroughs in key indicators such as specific activity, thermal stability, batch-to-batch consistency, and clinical performance of ALP. This realization of independent innovation in core raw materials provides critical support for downstream diagnostic reagents in terms of performance enhancement, cost optimization, and the construction of a complete industrial chain, driving the industry toward higher value-added segments.

Hzymes’ Technological Breakthrough: Advancing a Fully Localized Value Chain

True substitution begins with performance surpassing. The breakthrough achieved by Hzymes’ ALP is not a simple replication of existing processes, but rather a reconstruction based on fundamental technological principles.

Advantage 1: Innovation at the Source

Breaking away from the limitations of traditional extraction-based approaches, Hzymes adopts gene engineering and directed evolution technologies. Recombinant bovine intestinal alkaline phosphatase is produced using a Pichia pastoris expression system, with precise optimization of its glycosylation modifications. This critical step not only significantly increases yield, but also directly endows the enzyme with higher specific activity, improved thermal stability, and reduced nonspecific adsorption, fundamentally addressing the requirements for “high specific activity,” “high sensitivity,” and “high stability.”

Advantage 2: Ecosystem Development

By replacing the conventional sodium periodate coupling method with an SMCC-based strategy, followed by purification using S-300 molecular sieves to remove free streptavidin (SA), Hzymes obtains SA-ALP conjugates with high stability and minimal batch-to-batch variation. This enables full control from core raw materials to complete solutions. In addition to mastering the synthesis processes of key substrates such as CDP-Star, AMPPD, and APS-5, Hzymes can also provide integrated “enzyme–label–substrate” solutions, ensuring synergistic performance among components and optimal detection outcomes, thereby achieving true end-to-end autonomy.

Beyond Substitution: A New Standard for High-Performance Alkaline Phosphatase

1. High Specific Activity

Three batches of Hzymes’ in-house ALP and two batches of imported ALP products were evaluated. The results showed that the specific activity of all three Hzymes batches was higher than that of the imported products.

2. High Sensitivity

Five versions of PCT assay antibodies were labeled and compared: Hzymes low-glycosylation version, Hzymes high-glycosylation version, an imported product, and two domestic competitors. Thirty clinical PCT samples were randomly selected and tested on a chemiluminescent immunoassay analyzer. The results demonstrated that both the low- and high-glycosylation versions from Hzymes outperformed imported and domestic counterparts in terms of background luminescence and low-end sensitivity.

3. High Stability

Five versions of PCT antibody conjugates were evaluated under accelerated thermal stability conditions at 37 °C for 7 days. The results showed that both the low- and high-glycosylation versions of Hzymes’ ALP-labeled PCT products exhibited higher signal retention rates than the imported product and the two domestic competitors.

4. Controlled Batch-to-Batch Variation

Three batches of Hzymes’ low-glycosylation ALP were used to label PCT antibodies, and PCT calibrators were tested. The results indicated that batch-to-batch variation could be controlled within 10%.

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