RESUMO
Escherichia coli-derived (Serine 17) human interferon-beta (HuIFN-beta SER) was formulated with SDS and placed at multiple isothermal temperatures (-70 degrees C to 37 degrees C). Three stability-indicating test methods (bioassay, SDS-PAGE, RP-HPLC) were used to evaluate the long-term stability of this preparation. No change was observed when stored for nearly a year at either -70 degrees C or 4 degrees C. At the elevated temperatures, proteolytic cleavage, noncovalent oligomer formation, and loss of antiviral activity were observed. The absence of a carrier protein makes this stable IFN-beta frozen reference preparation useful as a standard in both biological assays and protein chemical methods of analysis.
Assuntos
Interferon Tipo I , Interferon beta , Proteínas Recombinantes , Bioensaio , Cromatografia Líquida de Alta Pressão , Estabilidade de Medicamentos , Eletroforese em Gel de Poliacrilamida , Humanos , Interferon beta-1a , Interferon beta-1bRESUMO
Escherichia coli-derived Tumour Necrosis Factor (TNF) was formulated in the absence of a protein-carrier, both as a solution and as a lyophilized preparation. By means of three stability-indicating test methods (bioassay, SDS-PAGE, IEF), the long-term stability of these TNF preparations was evaluated. Both preparations showed no change upon storage for 9 months at -70 degrees C and -20 degrees C. Depending upon the test method, different rates of change were detected at elevated temperature. The analysis presented will assist in the design of future TNF reference standards.
Assuntos
Proteínas Recombinantes/normas , Fator de Necrose Tumoral alfa/normas , Sequência de Aminoácidos , Animais , Sobrevivência Celular/efeitos dos fármacos , Deleção Cromossômica , Estabilidade de Medicamentos , Genes , Camundongos , Mutação , Controle de Qualidade , Proteínas Recombinantes/farmacologia , Soluções , Temperatura , Fatores de Tempo , Fator de Necrose Tumoral alfa/genética , Fator de Necrose Tumoral alfa/farmacologiaRESUMO
The antiviral activity of Escherichia coli-derived (Serine-17) human interferon-beta, formulated with human serum albumin, is stable for 2 years when lyophilized and stored under refrigeration. This product shows an Arrhenius line fit for the stability of its activity when tested at multiple isothermal temperatures (25-80 degrees C). In both isothermal and nonisothermal elevated temperature studies, increasing the level of human serum albumin in the formulation results in increased thermal stability.
Assuntos
Interferon Tipo I/farmacologia , Interferon beta , Proteínas Recombinantes/farmacologia , Vírus da Estomatite Vesicular Indiana/efeitos dos fármacos , Linhagem Celular , Estabilidade de Medicamentos , Escherichia coli/genética , Humanos , Interferon Tipo I/genética , Interferon beta-1a , Interferon beta-1b , TermodinâmicaRESUMO
The relative activity of Flavobacterium whole cells on the enzymatic synthesis of epoxides from alpha,beta-chlorohydrins, -bromohydrins, and -iodohydrins is described.