RESUMO
Antibody leakage from immunoaffinity chromatography (IAC) matrices could reduce the working life of the IAC matrix and/or contaminate parenteral products, purified by IAC. There is therefore a need to measure the leakage of antibody from IAC matrices and to reduce such leakage. Using sensitive ELISAs it was found that the type of activated matrix, the buffer, the presence of proteases in the feedstock and the storage of IAC matrices between runs could all effect antibody leakage.
Assuntos
Anticorpos Monoclonais/isolamento & purificação , Cromatografia de Afinidade/métodos , Brometo de Cianogênio , Imidazóis , Técnicas de Imunoadsorção , Sefarose/análogos & derivados , Animais , Biotina , Ensaio de Imunoadsorção Enzimática , Estudos de Avaliação como Assunto , Hormônio Foliculoestimulante/imunologia , Hormônio Foliculoestimulante/isolamento & purificação , Subunidade beta do Hormônio Folículoestimulante , Humanos , Camundongos , Ratos , Tireotropina/imunologia , Tireotropina/isolamento & purificaçãoRESUMO
This paper reports a comprehensive study of the biological stability of an immunoaffinity purified preparation of human thyroid stimulating hormone (TSH) and provides a reference against which future natural or synthetic preparations may be compared. The stability of the hormone preparation was investigated using the accelerated degradation method. The bioassay of the TSH was carried out in mice using a modified McKenzie method. Analysis of the results showed that the preparation was as stable as other TSH preparations purified by conventional methods.
