What You Must Know About IVD Core Biomaterials - Enzymes

With the leap-forward progress of the in vitro diagnostic reagent industry, a complete industrial chain has now been formed, including the supply of raw materials from upstream manufacturers, the R&D, production and sales of finished reagents in the midstream, and the demand for downstream markets. Among them, the supply quality of the core raw materials of the upstream manufacturers is very critical, which directly determines the development of the following reagent products, such as the upstream core raw materials: enzymes, antigen antibodies, buffers, blood collection tube additives, chromogenic substrates, luminescent reagents, etc., all must require Refinement production. Below, we will introduce the core raw material, which is widely used, enzyme.

I. Basic principles of raw material enzyme research and development

The main way to obtain enzymes is through purification, so protein purification technology and antibody preparation technology have become the key and basic principle of active raw material development, which may involve multiple disciplines.

II. Large-scale preparation of raw material enzymes

The whole preparation process includes several steps, raw materials preparing, pretreatment, primary purification, and precise purification. The preparation raw materials are directly selected from animal and plant cells or obtained by genetic means. The pretreatment of raw materials is to use some means to break the cells and tissues. It can also be processed by repeated freezing and thawing or surfactants. However, it is necessary to pay attention to the strength of breaking the tissue cells. Sometimes the strength is small and the release is not sufficient. , the strength is large, it will denature it, and the raw material will gradually become turbid after being broken, which can be removed by centrifugation.

The primary purification is carried out by means of precipitation or centrifugal filtration, commonly used ammonium sulfate precipitation, or precipitation using some organic solvents. Precise purification methods are mainly based on various separation chromatography based on molecular structure size, distribution or hydrophilic and hydrophobic properties, including ion exchange chromatography, hydrophobic chromatography, etc.

III. Preservation of raw material enzymes

The factors that affect the state of the solution of the enzyme active raw material include changes in pH value, ionic strength, storage conditions, and repeated freezing and thawing times. Usually, it can be stabilized by adding a series of buffer systems, inhibitors or reducing agents. The most common is Freeze-dried for storage.

IV.Quality control of raw material enzymes

The key to control the quality of the enzyme is to identify the raw material enzyme after batch purification, including concentration and purity, activity identification, the more commonly used methods are enzyme-linked immunosorbent assay or protein quantification, and the enzyme raw materials sold at the factory should be high. Purity, high activity, appearance and concentration are up to standard.

Desheng Biochemical is a professional manufacturer of various enzyme preparations. The enzyme has high activity, does not interfere with the experiment, and provides test reports. Up to now, it has been more than 10 years in the development of in vitro diagnostic reagent raw materials. Not only has rich experience, but also the products are constantly updated and upgraded to keep up with the pace of the market. If you have any needs, please click on the website for more information!