RESUMO
We used a rapid antigen test for the detection of carbapenemases directly from positive blood culture bottles of pediatric hemato-oncologic patients, known carriers of carbapenemase-producing enterobacteriaceae. Resistance mechanism was detected within 15 minutes of observing Gram-negative bacilli from a positive bottle, leading to treatment modification. This simple-to-use, inexpensive assay shortens the interval between empiric to tailored antimicrobial therapy.
Assuntos
Antígenos de Bactérias/sangue , Proteínas de Bactérias/biossíntese , Enterobacteriáceas Resistentes a Carbapenêmicos/enzimologia , Enterobacteriáceas Resistentes a Carbapenêmicos/isolamento & purificação , Cromatografia de Afinidade/métodos , Infecções por Enterobacteriaceae/microbiologia , beta-Lactamases/biossíntese , Adolescente , Antibacterianos/farmacologia , Proteínas de Bactérias/análise , Hemocultura/economia , Hemocultura/métodos , Enterobacteriáceas Resistentes a Carbapenêmicos/classificação , Enterobacteriáceas Resistentes a Carbapenêmicos/efeitos dos fármacos , Criança , Pré-Escolar , Cromatografia de Afinidade/economia , Cromatografia de Afinidade/instrumentação , Cromatografia de Afinidade/normas , Infecções por Enterobacteriaceae/diagnóstico , Feminino , Humanos , Lactente , Masculino , Testes de Sensibilidade Microbiana , Sensibilidade e Especificidade , beta-Lactamases/análiseRESUMO
The advantages of continuous chromatography with respect to increased capacity are well established. However, the impact of different loading scenarios and total number of columns on the process economics has not been addressed. Here four different continuous multicolumn chromatography (MCC) loading scenarios are evaluated for process performance and economics in the context of a Protein A mAb capture step. To do so, a computational chromatography model is validated experimentally. The model is then used to predict process performance for each of the loading methods. A wide range of feed concentrations and residence times are considered, and the responses of operating binding capacity, specific productivity, and the number of process columns are calculated. Processes that are able to add more columns proved to be up to 65% more productive, especially at feed concentrations above 5 g L-1 . An investigation of the operating costs shows that discrete column sizing and process performance metrics do not always correlate and that the most productive process is not necessarily the most cost effective. However, adding more columns for the non-load steps at higher feed concentrations allows for overall cost savings of up to 32%.
Assuntos
Biotecnologia/métodos , Cromatografia de Afinidade/economia , Cromatografia de Afinidade/instrumentação , Modelos Químicos , Reatores Biológicos , Biotecnologia/economia , Cromatografia de Afinidade/normas , Simulação por Computador , Redução de Custos , Proteína Estafilocócica A/químicaRESUMO
The purpose of this paper is to provide a summary of a BPOG-led industry survey of the microbiological control aspects of affinity chromatography processing in the biopharmaceutical industry. The document provides a summary of historical microbiological control concerns, coupled with industry-derived best practices, for material, equipment, and storage controls required to mitigate the potential for microbial ingress and contamination of chromatography resin and equipment. These best practice guidelines, which are derived from the members of the BPOG Bioburden Working Group, are intended to assist biopharmaceutical manufacturers to enhance microbial control and monitoring strategies for chromatography systems.