Hemarus Therapeutics Limited

Uma Devi Komath

Zinia Chakraborty

Ashok Kumar Nuvula

Mitali Samaddar

Swapna Sagar Duggineni

Neelima Vadde

Vvs Sailesh Bavirisetti

Thirupati Reddy Katkuri

The present invention relates to a chromatographic process for obtaining purified fibrinogen and thrombin from human plasma. The purified fibrinogen and thrombin preparations contain plasminogen in amounts less than 1 ug/mL. The low levels of plasminogen eliminates use of a proteolytic inhibitor, such as aprotinin in fibrin sealant kits which are used for human therapeutic applications.

Chromatographic process for producing high purity fibrinogen and thrombin

The invention is an integrated process for the isolation and purification of plasma derived clotting Factor VIII, clotting Factor IX, albumin and immunoglobulin without the use of ethanol precipitation. The integrated process comprises of sequential chromatography steps of gel filtration, anion exchange and cation exchange chromatographies, followed by viral inactivation and removal steps. The present invention has the advantage of being a mild process that does not denature or aggregate the proteins and provides high yields of several therapeutic grade plasma proteins from a given volume of plasma.

Integrated process for the production of therapeutics (human albumin, immunoglobulins, clotting factor VIII and clotting factor IX) from human plasma

The present invention discloses a preparation method for large scale production of human immunoglobulins (IgG) with high yields by an improved all-chromatography process scheme that eliminates ethanol precipitation. The process of extracting immunoglobulins is such that the other therapeutic proteins in plasma are left unaffected and are available for extraction separately from the same plasma sample. The yields obtained are in the range of 7 to 8 grams of IgG per liter of plasma. The high yielding process scheme of the present invention comprises of chromatographic steps and viral inactivation or removal steps to obtain a purified immunoglobulin protein that complies with pharmacopoeial limits and is suitable for therapeutic administration (normal intravenous immunoglobulin&#x2014;IVIG).

Process for increased yield of immunoglobulin from human plasma

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Hyderabad Telangana, India

Uma Devi Komath