Abstract:
The invention relates to the development of in vitro assay systems that force the release of a water-soluble polymer, such as polyethylene glycol (PEG) and polysialic acid (PSA), from proteins modified with a reversibly-linked water-soluble polymer. The invention includes methods for analyzing the release of the water- soluble polymer and measuring regained protein activity. The invention further includes methods appropriate for the quality control of proteins modified with releasable water-soluble polymers, including polymers like PEG and PSA.
Abstract:
The present invention relates to a method for determining an effective dose of monochromatic or polychromatic light from one or more light sources to inactivete microorganisms present in a biological fluid, preferably a non-trannsparent fluid. Moreover, there is provided a method for the inactivation of microorganism in a biological fluid in a flow-through-reactor. Moreover, the invention advantageously provides a flow-through-reactor with one or more thermostated light sources. The invention further provides a method of controlling the light sum dose of monochromatic or polychromatic light emitted from one or more light sources to effectively inactivate microorganisms present in a biological fluid in a batch reactor.
Abstract:
The present invention relates to a method for determining an effective dose of monochromatic or polychromatic light from one or more light sources to inactivete microorganisms present in a biological fluid, preferably a non-trannsparent fluid. Moreover, there is provided a method for the inactivation of microorganism in a biological fluid in a flow-through-reactor. Moreover, the invention advantageously provides a flow-through-reactor with one or more thermostated light sources. The invention further provides a method of controlling the light sum dose of monochromatic or polychromatic light emitted from one or more light sources to effectively inactivate microorganisms present in a biological fluid in a batch reactor.
Abstract:
A validatable method for determining a photochemically effective dose for inactivating pathogens in a fluid sample is described herein. In particular, the instant invention covers methods for determining a photochemically effective doses sufficient to inactivate pathogens in a biological sample while leaving biologically active substances of interest unaffected. A batch irradiation reactor effective for inactivating pathogens in biological samples is also described.
Abstract:
The present invention relates to a method for the determination of polysorbate in a protein-containing sample. The method of the present invention involves the pretreatment of the sample by alkaline hydrolysis followed by colorimetric determination on the basis of the metal complex of the analyte with a thiocyanate reagent, the complex being extracted in an immiscible organic solvent. The alkaline hydrolysis accounts for the removal of the interfering proteins and enhance selectivity over surfactants similar to the analyte, e.g. for Tween 80 over Triton X-100.
Abstract:
The invention relates to the development of in vitro assay systems that force the release of a water-soluble polymer, such as polyethylene glycol (PEG) and polysialic acid (PSA), from proteins modified with a reversibly-linked water-soluble polymer. The invention includes methods for analyzing the release of the water- soluble polymer and measuring regained protein activity. The invention further includes methods appropriate for the quality control of proteins modified with releasable water-soluble polymers, including polymers like PEG and PSA.
Abstract:
Un método in vitro de liberación de un polímero soluble en agua ligado de manera reversible de una proteínamodificada mediante el polímero soluble en agua o aumento de la actividad de una proteína modificada con unpolímero soluble en agua ligado de manera reversible que comprende la etapa de incubar la proteína en condicioneseficaces para liberar el polímero soluble en agua, en el que las condiciones eficaces para liberar el polímero solubleen agua comprenden aumentar la concentración de amina libre de un tampón que comprende la proteína por adiciónde lisina libre, histidina o una combinación de las mismas al tampón en una concentración eficaz para liberar elpolímero soluble en agua.
Abstract:
The present invention relates to a method for the determination of polysorbate in a protein-containing sample. The method of the present invention involves the pretreatment of the sample by alkaline hydrolysis followed by colorimetric determination on the basis of the metal complex of the analyte with a thiocyanate reagent, the complex being extracted in an immiscible organic solvent. The alkaline hydrolysis accounts for the removal of the interfering proteins and enhance selectivity over surfactants similar to the analyte, e.g. for Tween 80 over Triton X-100.