![]() For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. In addition, the NRC produced and characterized the spike protein of the SARS-CoV-2 virus that was used in the testing.Īltasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. ![]() It was a truly collaborative achievement.”Īltasciences has over 260 laboratory sciences experts specialized in bioanalysis, ligand binding assays, mass spectrometry, immunology, biomarkers, and molecular biology generating the quality data needed for successful preclinical to clinical drug and vaccine development.Īltasciences worked with the NRC to test various antigens and select the best reagents for the assay. We are proud of the success of this qualification, which could not have been achieved without seamless teamwork, scientific expertise in vaccine assay development, and the source of study subject patient serum from Altasciences’ clinics (both with and without SARS-CoV-2 infection) that were needed to qualify the assay. ![]() The assay was qualified in a GLP laboratory, using a source of spike protein that is reliably and robustly produced in Canada. Lynne Le Sauteur, Vice President, Laboratory Sciences, shares what makes this assay qualification unique: “This assay is different from other developments in that it is quantitative, giving an indication of the magnitude of the antibody response, whereas other assays typically provide qualitative yes/no results. Days of hospitalization, days missed from school and work, adverse events from the IVIG and SCIG therapy were reviewed and included if reported ( Table 2).This advertisement has not loaded yet, but your article continues below. The annual rate of infection per patient was calculated, when not provided, for statistical analysis. However, due to the low number of pneumonia diagnoses reported in the studies, regression analysis was focused on overall infections and serious infections. Pneumonia was also sometimes reported as a "serious infection" separating it from the overall infections diagnosed during the treatment period. Reported details on criteria for pneumonia diagnosis during the course of treatment with IVIG and SCIG therapy were limited, with some studies reporting the diagnosis based on history, chest X-ray, physical exam and need for hospitalization. Patients with chronic infections with Hepatitis B, C or HIV, on antibiotics, abnormal liver and renal function tests, severe neutropenia, thrombotic episodes, malignancy, currently receiving immunosuppression, pregnant or nursing were excluded in most studies. However, in one study done by Borte et al., patients above 2 years of age with PIDD requiring 0.3–1 g/kg IgG for ≥ 3 months with serum IgG trough 5 g/l only were included. Inclusion criteria of the studies stipulated documented diagnosis of PIDD requiring IgG therapy with a stable dose and trough level. ![]() After reviewing the quality of studies, 11 studies were compared in the meta-analysis for trough levels as depicted in the forest plot ( Fig. 2). Trough levels calculated in studies varied in terms of timing, with most of the levels drawn prior to the next IVIG and SCIG infusion. IVIG administration frequency was every 3 or 4 weeks, whereas, SCIG dose was given weekly. IVIG had been used in all the studies as a historical form of IgG administration and was compared with SCIG in 15 studies. Synonyms for immunoglobulins included "immunoglobulins", “intravenous”, “subcutaneous” abbreviations of IVIG, SQIG, as well as specific brand names such as Carimune, Gammagard, and subject headings which included specific routes of injection such as immunoglobulins/intravenous or immunoglobulins/subcutaneous were included. Synonyms for immune deficiency included "immunologic deficiency syndromes", "common variable immunodeficiency", "dysgammaglobulinemia", "agammaglobulinemia", "hypogammaglobulinemia" (the text words allowed for both American and British spellings). Search terms and synonyms for "immunologic deficiency" and "immunoglobulins" were combined in the search with "AND" using Boolean logic. A combination of subject headings (MeSH, EMTREE) and text words was used for each concept. Searches of MEDLINE, EMBASE, Cochrane Library, and Scopus databases were carried out to identify eligible studies. We focused our review on studies after 2010 to cover newer studies since the recent advancements in the treatment of these diseases.
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