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Plasma and plasma protein therapeutics

Plasma and Plasma Protein Therapeutics

Plasma is the protein-rich fluid that suspends the cells in blood. It performs many important transport functions, and the proteins found in plasma play critical roles in clotting and providing immunity to diseases.

When isolated from plasma through a complex manufacturing process, these proteins become important medical therapies. Plasma proteins are used to treat many conditions including:

  • immune deficiencies
  • autoimmune disorders
  • neurological & bleeding disorders
  • shocks and burns

The number of patients that require these therapies continues to grow rapidly.

Learn more about our plasma proteins by visiting our Pipeline section.

Collecting Plasma

The process of collecting plasma starts with the generosity of healthy volunteer donors. Plasma can be extracted in two ways: from whole blood donations (recovered plasma), or more commonly through specific plasma donation (source plasma).

Source plasma donation is similar to a blood donation but it incorporates a process called plasmapheresis, where the cellular components of the blood (red blood cells, white blood cells and platelets) are separated from the plasma and returned to the donor, while the plasma is retained. The plasmapheresis process is sterile, self-contained and automated. Donors provide the raw materials needed for life-saving and life-sustaining therapies.

The collection of plasma in Canada is regulated by Health Canada and by the Food and Drug Administration (FDA) in the United States. Plasma collection centers may also undergo additional certification in the voluntary International Quality Plasma Program (IQPP) that was developed by the Plasma Protein Therapeutics Association (PPTA), an international trade and advocacy organization. These standards not only ensure the safety of the donors, but also that the plasma collected and used to manufacture drugs is of the highest possible quality.

Manufacturing Process

Plasma proteins are only a small component of plasma, which is made up mostly of water. This means it takes a lot of plasma to make therapeutics. Having an efficient process to manufacture plasma proteins is highly desirable.

All commercial manufacturers currently serving the North American market extract plasma proteins using a process called “fractionation” that was developed in the 1940s and includes manufacturing steps using cold alcohol and salt and pH adjustments.

We are developing an efficient new and proprietary chromatography process for manufacturing plasma proteins. It has demonstrated high yields for existing therapies and provides for potential access to novel therapies of high quality and purity from the precious supply of plasma to address unmet patient demands. Therapure is currently manufacturing its lead therapy at clinical scale in preparation for in human trials in 2017.

The manufacturing of these products is regulated by Health Canada and by the FDA in the United States. Additionally the Plasma Protein Therapeutics Association’s (PPTA’s) Quality Standards of Excellence, Assurance and Leadership (QSEAL) program goes beyond the regulations to ensure highest quality and safety of the final products.