The development and production of biotherapeutics, including monoclonal antibodies, recombinant proteins, and gene therapy vectors, require rigorous control of process- and product-related impurities. These impurities can influence the safety, efficacy, and stability of the final therapeutic product. As regulatory agencies increasingly emphasize the importance of critical quality attributes (CQAs), enzyme-linked immunosorbent assays (ELISAs) have emerged […]
Semaglutide: An Overview Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, has gained considerable attention in the past couple of years due to its potential applications in both the treatment of diabetes and weight loss/metabolism. With US FDA and EMA approvals in place (Ozempic and others) and related GLP-1 agonist analogs being developed, it is crucial […]
CHO Cells How Chinese Hamster Ovary Cells are the Unwavering Champion of Biologics Production The biopharmaceutical industry is witnessing remarkable growth with the development of innovative protein-based therapies. Behind this revolution stands a silent yet powerful champion: Chinese Hamster Ovary (CHO) cells. These cells have become the gold standard in biopharmaceutical production, playing a vital […]
Technical Note: Neutrophils and their Markers Neutrophils form the first line of defense against invading pathogens. These abundant granulocytes, constituting 50-70% of circulating white blood cells, are the body’s rapid responders, armed with potent antimicrobial weaponry and an impressive arsenal of cell surface markers. A part of the polymorphonuclear cells family (PMNs) together with basophils and eosinophils, they are formed […]
Technical Note: Validation of Krishgen ELISA for Accurate, Reproducible Results Krishgen ELISA are always fully validated using a stringent, thorough protocol that guarantees quality and performance. They are designed and developed to meet high standards set by the best manufacturers around the world. In this blog, learn more about our validation process. Optimization Optimization of […]
Technical Note: Use of anti-idiotypic antibodies in ELISA and a review on the better specificity offered Background: KRISHGEN Therapeutic Drug Monitoring ELISA for estimation of the drug or Immunogenecity ELISA for quantification of anti-drug-antibodies are well validated and sensitive as the critical source reagents – the coating and detection antibodies used for a majority of […]
Technical Note: Free, Bound, and Total Drug Estimation of monoclonal antibody drugs Understanding the pharmacokinetic and pharmacodynamic behavior of a given therapeutic drug is an essential element of understanding its effectiveness and safety, as well as identifying the proper dosage, combinations and distribution. All pre-clinical and clinical studies include the measurement of serum drug concentration […]
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