The outbreak of Covid-19 infection has become a pandemic affecting millions of people throughout the world. No specific antiviral drugs have been approved for the treatment of Covid-19. The antiretroviral drug favipiravir (FAV) has been experimentally used for COVID-19 treatment since March 2020 in Japan. China’s Science and Technology Ministry official announced that Japan-based anti-flu drug FAV has been observed to help Covid-19 patients recover.
Heberprot-P® is a therapeutic product approved in Cuba for the treatment of diabetic foot ulcer.In spite of its ample clinical use, its immunogenicity in patients has not been evaluated.Regulatory agencies have developed guidelines for the validation of immunoassays designed at the detection of anti-drug antibodies to biologicals.The aim on this work was to validate a method for the detection of binding antibodies in human serum to recombinant human epidermal growth factor (rhEGF), the active ingredient of Heberprot-P®.A two-tiered enzyme-linked immunosorbent assay (ELISA) format was used.First tier was a screening assay, based on immobilized rhEGF and anti-human polyvalent alkaline-phosphatase conjugated as development reagent.Positive samples were then tested with a confirmatory assay which used a competitive soluble rhEGF in solution.As FDA and EMA guidelines recommend, minimum required dilution, quality controls, screening and confirmatory cut points, sensitivity, recovery, precision, specificity, selectivity, robustness and stability of samples were determined.The assay was precise and its sensitivity was calculated to be 214.2ng/mL.The majority of evaluated parameters fulfilled the figures recommended by current guidelines.The immunoassays described in this work could be reliable tools for the evaluation of immunogenicity of Heberprot-P® in well-designed clinical studies.
Following an accumulation of incidences of thromboembolic events after administration of certain immunoglobulin G (IgG) brands in 2010 and 2011, regulatory agencies also required other therapeutically used IgG preparations to be checked for the presence of procoagulant activities. Additionally, their manufacturing pathways had to be investigated for steps that have the capacity to reduce procoagulant activities.
Conflicting historical data for the specific refractive index increment dn/dc of human plasma/serum protein have warranted an experimental re-calibration for citrated source plasma for fractionation. Measurements by Dumas combustion and digital refractrometry applied the pharmacopeial protein-nitrogen ratio of 6.25. The non-protein matrix was separated by centrifugal ultrafiltration. Refractometric data agreed excellently with Dumas-based protein concentrations.
Studies have shown that the ratio of n-6:n-3 fatty acids in red cell membranes provides an objective biomarker of the relative intakes of westernized and traditional diets. Thus, an increase in the ratio is associated with risk for the development of westernized diseases. Whole human blood was analyzed for targeted omega-6 and omega-3 fatty acids. An aliquot was washed with Dulbecco's Phosphate Buffered Saline and centrifuged to form a pellet.
