摘要:
Process for preparing a purified immunoglobulin preparation. The process comprises the steps of subjecting a crude immunoglobulin solution to caprylic acid treatment, removing protein aggregates and viruses from the immunoglobulin solution, subjecting the immunoglobulin solution to anion exchange chromatography in order to purify the immunoglobulin, filtering the immunoglobulin solution thus obtained on a virus-removal filter to produce an eluate containing immunoglobulin, and recovering the immunoglobulin. By combining caprylic acid treatment and precipitation with a protein precipitant the level of aggregated proteins and viruses is effectively reduced and a truly virus safe preparation is provided after filtration.
摘要:
The invention relates to a method for the treatment of a blood plasma preparation in order to inactivate possible viruses in the preparation. In the method, ascorbate and photoactive substance such as phenothiazine dye are added to the preparation, and the preparation is irradiated at a wavelength which excites the photoactive substance.
摘要:
The present invention concerns a method of preparing pharmaceutical compositions of a biologically active proteins, in particular multicomponent interferon compositions. The invention comprises the steps of adding to a solution of the protein a non-ionic detergent in an efficient amount to provide an extended shelf-life of the pharmaceutical composition; subjecting the solution containing the non-ionic detergent to filtration on a virus removal filter with a pore size of 10 to 40 nm; and recovering the filtrate. The method gives rise to, e.g., a virus-safe multicomponent α-interferon composition, comprising a non-ionic detergent as a stabilizer in an amount exceeding the critical micellar concentration of the detergent and being essentially free from substances retained on a virus-filter having high virus retentive capacity.
摘要:
This invention relates to antibody engineering technology. More particularly, the present invention relates to human IgM antibodies and derivatives thereof, which have novel binding specificity with regard to several oligosaccharide sequences and/or xenoantigenic sialic aicd residue. The present invention also relates to processes for making and engineering such novel saccharide and/or NeuGc-binding monoclonal antibodies and to methods for using these antibodies and derivatives thereof in the field of immunodiagnostics, enabling qualitative and quantitative determination of xenoantigenic NeuGc in biological and raw material samples, as well as in immunotherapy, enabling blocking of xenoantigenic NeuGc in patients.
摘要:
The present invention relates to pharmaceutical compositions of transferrin and to the manufacture of such preparations. The present invention concerns specifically a pharmaceutical composition of apotransferrin, the iron-free form of transferrin, wherein the composition has at least 90 % of the theoretical iron binding capacity of iron-free transferrin, contains less than 3 % transferrin dimers and no detectable transferrin polymers or aggregates, and has an iron-saturation of less than 5 %. The pharmaceutical apotransferrin composition of this invention effectively binds non-transferrin-bound-iron to a harmless form when administered as an intravenous injection or infusion to patients. The pharmaceutical composition of this invention does not contain viruses, denatured forms of transferrin or other harmful components.
摘要:
The present invention relates to pharmaceutical compositions of transferrin and to the manufacture of such preparations. The present invention concerns specifically a pharmaceutical composition of apotransferrin, the iron-free form of transferrin, wherein the composition has at least 90 % of the theoretical iron binding capacity of iron-free transferrin, contains less than 3 % transferrin dimers and no detectable transferrin polymers or aggregates, and has an iron-saturation of less than 5 %. The pharmaceutical apotransferrin composition of this invention effectively binds non-transferrin-bound-iron to a harmless form when administered as an intravenous injection or infusion to patients. The pharmaceutical composition of this invention does not contain viruses, denatured forms of transferrin or other harmful components.
摘要:
The invention relates to a method for the treatment of a blood plasma preparation in order to inactivate possible viruses in the preparation. In the method, ascorbate and photoactive substance such as phenothiazine dye are added to the preparation, and the preparation is irradiated at a wavelength which excites the photoactive substance.