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Plasmapharm LLC

PlasmaPharm provides access to fractionation technology „Onix-method“ a universal technology process

We provide technical solutions to the human blood plasma fractionation industry, meeting the most stringent requirements of the industry by concomitantly integrating technology, process knowledge and quality systems and training. Our interdisciplinary approach and vast knowledge of the particular features of plasma fractionation make us the preferred partner for fractionation facility/technology projects.

Techniques

Precipitations, chromatographic separations, membrane filtration, viral inactivation techniques (pasteurization, solvent/detergent, pH-treatment, etc.), sterile filtration, aseptic filling, freeze drying. 

Onix-method: a Plasma Fractionation by Cohn and Kistler, Nitschmann

  • Paste recovery by centrifugation or filter press technology.
  • Intermediate purification: chromatography steps, precipitation and ultrafiltration.
  • Virus removal is performed utilizing well-known technologies including pasteurization, solvent/detergent, acidic pH, (nanofiltration optional).
  • All pdmPs comply with the respective EU Ph. Eur. monographs
  • IgG complies in addition with WHO recommendation on IgG.

The Onix Process: the perfect combination of chromatography and Cohn Fractionation stands out for its industrial scalability, cost-effectiveness, robust product quality, operational flexibility, and strong business risk mitigation features compared to competing alternative plasma extraction and purification technologies.

Plasmapool

Recovered and Source Plasma

Cryoprecipitate

Factor VIII
Other coagulation factors

Paste II

Immunoglobulin G

Paste V

Human Albumin

Available Plasma derived medicinal Products from Onix

PlasmaPharm licenses the manufacturing technology and nonexclusive market authorizations for all listed products. We support the dossiers with eCTD documentation, which needs to be adapted for the target country; registration by the licensee.

Immunoglobulin Products

Subcutaneous IG 16%

Intravenous IG 5%, 10%

Anti-RhD

Anti-HAV

Anti-Tetanus

Anti-CMV

Anti-Measles

Anti-Rabies

Clotting Products

Factor VIII

Factor IX

PPSB

Fibrinogen

Albumin Products

Albumin 4%, 5%

Albumin 20%, 25%