Awards & patents.

Degarelix is used for the treatment of advanced prostate cancer. Degarelix is a synthetic peptide derivative drug which binds to gonadotropin-releasing hormone (GnRH) receptors in the pituitary gland and blocks interaction with GnRH. This antagonism reduces luteinizing hormone (LH) and follicle-stimulating hormone (FSH) which ultimately causes testosterone suppression. Reduction in testosterone is important in treating men with advanced prostate cancer. US FDA approved the same as drug under the trade name "Firmagon" in December 2008.

The ELISA is a competitive immunoassay for the determination of Degarelix. A constant concentration of Degarelix coated on the microplate and varying concentration of standard or sample will compete for binding to degarelix agonist. Detection antibody against the agonist conjugated to HRP is added to form a complex. The complex will produce a soluble colored product on substrate addition. The enzyme reaction is stopped by dispensing of Stop Solution into the wells. The optical density (OD) of the solution at 450 nm is inversely proportional to the amount of bound Degarelix present in standards or samples.

"Immunoassay for quantitative estimation of Degarelix in human serum and plasma and cell culture supernatant as following Claims."

1. As per claim 1 it is prescribed that it is easy to use antibody-based immunoassay platform for sensitive, selective and reproducible detection of degarelix.
2. As per claim 1 it is prescribed that using specific proprietary coating and blocking technology, degarelix (as salt) is coated on the microwells retaining its activity and efficacy.
3. As per Claim 1 it is prescribed that the immunoassay provides fast and reproducible estimation of degarelix
4. As per claim 1 it is prescribed that to achieve highly sensitive and selective detection of degarelix, we evaluated and optimized the optimal concentration of the degarelix to be coated and the optimal concentration of the degarelix agonist and its antibodies to be used.
5. As per claim 1 it is prescribed that the assay platform showed a limit of detection (LOD) of degarelix less than 40 ng/ml and a dynamic range of 0 - 2000 ng/ml. Neither the assay showed any cross reactivity to PSA (prostate specific antigen) or LH (luteinizing hormone).

The KRIBIOLISA™ Atezolizumab (TECENTRIQ) Neutralizing Antibody ELISA is a competitive ligand binding assay (CLBA) for Qualitative Determination of Neutralizing Antibodies to Atezolizumab in human serum and plasma. Atezolizumab (trade name Tecentriq) is a fully humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death-ligand 1 (PD-L1). In 2015, it was in clinical trials as an immunotherapy for several types of solid tumors. It was under investigation by Genentech/Roche. In April 2016, Roche announced that atezolizumab had been granted fast track status for lung cancer by the FDA. Anti-Drug Antibodies (ADA) may induce unwanted side effects in biopharmaceuticals.

Hence, ADA has been subjected to increase in scrutiny by the regulatory authorities using immunogenicity safety studies. ADA has been observed in pre-clinical and clinical studies, resulting in significant changes in toxicology, pharmacokinetics and efficacy. These effects result from the generation of drug-induced (neutralizing) autoantibodies against Atezolizumab and can be responsible for allergic reaction, or even anaphylactic shock. This ELISA kit detects neutralizing antibodies for Atezolizumab and may be used for monitoring immunogenicity.

"The Enzyme Immunoassay for Qualitative determination of Atezolizumab Neutralizing Antibody in serum and plasma which define some claims as given"

1. As per claim 1, it is describe that the enzyme immunoassay revealed a higher specificity than the assays commercially available.
2. As per the claim 1, it is describe that the immunoassay detects antibodies which specifically neutralize Atezolizumab using a recombinant protein to bind and form a complex with the anti-his tag antibody and histidine detection conjugate.
3. As per the claim 1, it is prescribed that using specific proprietary coating and blocking technology, streptavidin is coated on the microwells and binds to a specific his-tag atezolizumab retaining its activity and efficacy.
4. As per Claim 1 it is prescribed that the immunoassay provides fast and reproducible estimation of neutralizing antibodies to Atezolizumab.
5. As per claim 1 it is prescribed that to achieve highly sensitive and selective detection of neutralizing antibodies, we evaluated and optimized the optimal concentration of the streptavidin to be coated and the optimal concentration of the his-tag antigen and anti-histidine conjugate to be used.