Process for the preparation of an immunoadsorbent matrix

Catalyst – solid sorbent – or support therefor: product or process – Solid sorbent – Organic

Reexamination Certificate

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C502S402000, C502S403000, C525S057000, C525S061000

Reexamination Certificate

active

06309999

ABSTRACT:

FIELD OF INVENTION
This invention relates to a process for the preparation of immunoadsorbent matrix based on modified polyvinyl alcohol microspheres and its use in columns for direct haemo-perfusion.
BACKGROUND OF INVENTION
Plasma exchange has become the most common and effective therapeutic treatment of various intractable disorders and neurological diseases. Unavailability and high price of plasma products, and risk of infections lead to the development of plasma treatment devices. Selective adsorption plasma treatment is now a well established clinical practice for the treatment of myasthenia gravis, Guillain-Barre syndrome (GBS), systemic lupus erythematosus (SLE) etc., but is only marginally cheaper than plasma exchange procedure, and the columns are meant for plasma perfusion only. However, this can eliminate the dependence of plasma products on plasmapheresis thereby avoiding risk of infections. Though various immunoadsorption columns for plasma perfusion only are available, it is still not known to have direct haemoperfusion columns. Further, it is not known to have devices that can simplify and reduce treatment cost further by achieving plasma separation and plasma treatment in a single device or direct haemo-perfusion.
An apparatus and method is known in the art which draws blood through a blood pump and a column, and functions as a plasma separator to cause a separation of the blood cells from the plasma. The plasma is then passed through an immunoadsorbent column so that IgG proteins get adsorbed in the adsorbent, and the treated plasma is then mixed with the removed blood cells and returned to the patient. The disadvantage of such a method and apparatus is that of substantial costs. Further, such a method is to be repeated once or twice and each time the column and plasma separator is to be replaced.
Yet another method and apparatus known in the art is to withdraw the blood of a patient, which is then centrifuged to remove the plasma, which is then replaced by fresh blood plasma from a donor. A disadvantage of such a method and apparatus is that of infection in the fresh blood of a donor. Further, hemolysis can occur in the centrifuge.
OBJECTS OF THE INVENTION
An object of this invention is to propose a process for the preparation of an immunoadsorbent matrix based on polyvinyl alcohol micropheres for direct haemo-perfusion.
A further object of this invention is to propose a process for the preparation of an immunoadsorbent matrix based on polyvinyl alcohol which can specifically remove IgG proteins from blood and is highly blood compatible.
A still further object of this invention is to propose an immunoadsorbent column based on the immunoadsorbent matrix for the specific removal of antibodies belonging to or consisting of immunoglobulins of the class G and circulating immune complexes.
Yet another object of this invention is to propose an immunoadsorbent column which can be used for direct perfusion of human patient blood for the treatment of IgG mediated disorders.
Another object of this invention is to propose an immunoadsorbent column for blood perfusion which may be applied clinically as a less complex and inexpensive alternative to plasma treatment devices.
Further objects and advantages of this invention will be more apparent from the ensuing description.


REFERENCES:
patent: 3673612 (1972-07-01), Merrill et al.
patent: 4028315 (1977-06-01), Bodanszky et al.
patent: 4329383 (1982-05-01), Joh
patent: 4387183 (1983-06-01), Francis
patent: 4530964 (1985-07-01), Machovich et al.
patent: 5071973 (1991-12-01), Keller et al.
patent: 5574097 (1996-11-01), Klaveness et al.
patent: 5760200 (1998-06-01), Miller et al.

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