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In Vitro Diagnostic (IVD) is a vital source of clinical diagnostic information, providing a significant reference for clinical therapeutic regimen. IVD can be categorized into biochemical diagnosis, immunodiagnosis, molecular diagnosis, point-of-care testing(POCT) and microbial diagnosis. Main IVD raw materials consist of antigen & antibody, enzyme & coenzyme as well as other raw materials, playing a basic but still most significant role in the whole IVD supply chain.
Antibody enjoys a wide application in various immune-diagnoses, which is one of the most commonly used raw materials in the IVD reagents. Generally speaking, the purification of antibody can be completed via affinity chromatography including Protein A or Protein D. The former (Protein A) can specifically bind with Fc fragments of IgG, whereas Protein G enjoys specific affinity with both Fc and Fab fragments due to a wider binding domain than Protein A, enabling its application in the purification of antibody from multi-source plasma, ascites and cell culture supernatant.
IVD raw materials in this category can be classified as tagged and untagged recombinant antigens & enzymes. The purification of untagged recombinant antigens & enzymes will go through initial purification by affinity chromatography resins, before the intermediate purification and polishing steps with IEX or SEC resins. His and GST tags are commonly used raw materials for IVD, which can be obtained via purification with Bestchrom’s Ni pre-packed column and GST pre-packed column, respectively.
For untagged proteins, purification can be achieved by combined method of IEX, HIC and SEC resins, or pre-activated resins coupled with specific ligands.
For the purification of other materials such as peptide and small molecule label, it is possible to choose the suitable resins according to the molecular weight, isoelectric points and hydrophobicity.
As the IVD market rapidly grows, establishing purification platform for raw materials becomes extremely significant. In order to eliminate the interference from impurities, improved purity for IVD raw materials via process optimization will significantly boost the quality of raw materials and performance stability of diagnostic kits.
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