Comparability study between downstream methodologies using physicochemical characteristics of hyperimmune serum for human use

• Autor(a) principal: Maciel-Fritoli, Gisele Pereira
• Data de Publicação: 2023
• Outros Autores: Silva, Ana Paula dos Santos, de Moura, Erickson Luiz, Hamm, Rafaela Kropzak Schmoeller, Perez, Elisa
• Tipo de documento: Artigo
• Idioma: eng
• Título da fonte: Brazilian Journal of Health Review
• Texto Completo: https://ojs.brazilianjournals.com.br/ojs/index.php/BJHR/article/view/59582
• topic: drug industry; quality control; orphan drug production; immunoglobulin fragments

This study compared two downstream methodologies of antivenom production and statistically evaluated the results of quality control between batches of Antiloxoscelic Serum (approved or not) of these methods. The methodologies present significant downstream differences related to the quality control results. The document analysis and statistical evaluation of the results were obtained using a control chart. All batches showed physical-chemical results within the specification limits, but not all downstream B results were within the process control limits. In all quantitative results analyzed (total protein, non-protein nitrogen, phenol, total solids, pH, chloride), it was possible to verify that the downstream B samples did not meet the process control criteria established by the control chart. The conclusion is that method B is outside the control of the stipulated production process.