Good Biotech Corp. has been recognized in the community as a leader as a polyclonal antibody & diagnostics manufacturer and therapeutics innovator. Good Biotech has received lots of honors and recognition; below are some of Good Biotech's awards.
Awarded “National Biotechnology and Medicine Care Quality Award” for” The new generation Duck IgY(ΔFc) new generation antibody and uses thereof”.
The National Biotechnology and Medical Quality Award has been held by the Institute for Biotechnology and Medicine Industry (IMBI), selection of biomedical products with the top achievements and international competitiveness, has the reputation of "Taiwan Biomedical Oscar". The award is a symbol of excellent quality and represents Safe and Quality (SNQ).
Awarded the Golden Award (The Best company) of the “Pharmaceutical Technology Research and Development” for “The new generation Duck IgY(ΔFc) new generation antibody derived biotherapeutics and uses thereof- CRPex-HS: The High Sensitivity of C Reaction Protein LIT Assay”.
The "Pharmaceutical Technology Research and Development Award" is a national-level award. The only national pharmaceutical science and technology award jointly held by the central authority of "the Ministry of Health and Welfare and the Ministry of Economic Affairs. The Award is divided into three categories: " Pharmaceuticals, "medical equipment" and "manufacturing technology" and each group has one final winner for Golden Award.
Introduction of the awarded product & Comments from the reviewers of the competition:
Highly sensitive CRP immunoassay-utilizes duck IgY(ΔFc) to minimize the risk of false-positive results
It is widely recongnized that slightly elevated levels of C-Reactive Protein (CRP) are associated with an increased risk of cardiovascular and peripheral vascular disease. Many different types of assays have been developed for the quantification of CRP and traditionally mammalian IgG antibodies are the major type of antibodies employed in these immunoassays. Additionally, with the increased use of monoclonal antibodies as diagnostic and therapeutic reagents, it is estimated that more than 10% of patients will develop human anti-mouse antibodies (HAMA) which may interfere with mammalian IgGs in immunoassays.
The CRPex C-Reactive Protein LIT Kit from Good Biotech Corp. utilizes duck IgY which is inactive to the human complement system and rheumatoid factors in mammalian sera. No cross-reactivity with mammalian IgG is observed which makes duck IgY(ΔFc) ideal for immunological assays involving mammalian sera. Duck IgY(ΔFc) has a higher avidity for detecting antigens in immunoassays than many traditionally used antibodies and by employing the duck IgY(ΔFc), the accuracy, precision, and sensitivity of the diagnostic reagents are greatly improved.
Good Biotech Corp. CRPex-HS CRP LIT Assay is intended to be used for the quantitative determination of C-reactive protein in serum by latex particle enhanced immunoturbidimetry (LIT). Highly sensitive measurement of C-reactive protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders, and associated diseases. The kit is the first IgY-based Human CRP immunoassay in the world and is FDA 510(k) cleared, CE certified with excellent sensitivity, specificity, and precision.
Awarded 10th “Small and Medium-sized Enterprise (SME) Innovation Award” for Good Biotech CRPex-HS C-Reactive Protein LIT Kit, by Ministry of Economic Affairs (MOEA), R.O.C.
Awarded 14th “Small and Medium-sized Enterprise (SME) Innovation Award” for Good Biotech Ferritin LIT Assay Kit, Ministry of Economic Affairs (MOEA), R.O.C.
Introduction of the awarded product:
Due to the trace amounts of ferritin present in human serum, the serum ferritin concentration has been generally determined by enzyme-linked immunosorbent assay (ELISA) or chemiluminescence immunoassay (CLIA). However, detection with ELISA is laborious and time-consuming and CLIA is restricted to perform on a special analyzer. Those are the main disadvantages of traditional ferritin assay kits. Ferritin LIT Assay developed by Good Biotech Corp. is a ready-to-use reagent for quantification of ferritin by latex microparticle enhanced immunoturbidimetry (LIT). A new type of antibody, duck IgY(ΔFc), has been employed in this test system. Duck anti-ferritin ferritin IgY(ΔFc) is coupled to latex particles, which amplifies the antigen-antibody reaction and thus greatly increases the detection sensitivity. The assay is simple, rapid, and can be cost-effectively performed on common automated chemistry analyzers. Duck IgY(ΔFc) antibody manufactured from duck egg yolk by patented proprietary technology offers the advantages of relatively good stability, high productivity, and low cost and is particularly suitable for industrial applications.
Comments from the reviewers of the competition:
This product provides a precise measurement of the ferritin concentration in human blood serum with a sensitivity of 4 ng/mL (normal values are between 10-200ng.mL). its primary application is for dialysis patients suffering from iron-deficient anemia. The independently developed latex micro-particles can be attached to different functional groups for other types of immune functional analysis. By exploiting the distinctive structure and phylogenetic difference of the Duck IgY(ΔFc) antibody, the kit is free from interference while the sensitivity is greatly improved to mammalian antigens. The product, Ferritin LIT Assay, is the first and only Taiwan-made ferritin assay and the development of Ferritin LIT Assay has a significant meaning for Taiwan’s biotechnology industry, especially in the IVD field. The product is FDA 510(k), CE certified, as well as unique, competitive, and with great market potential.
