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About Plasma
Plasma Safety

The immunoglobulin used in replacement therapy is made from human plasma. Plasma is the liquid portion of blood, which also contains red and white blood cells and platelets. Just like people can donate blood, they can also donate plasma.

People who take immunoglobulin therapy usually take it for their whole life. Because of this, the safety of their immunoglobulin is extremely important. To ensure the highest safety margins, Baxter has developed a state-of-the-art quality assurance process.

It starts with a rigorous screening and donation process.

Qualified Repeat Donors

Plasma is obtained from donors demonstrating a commitment to ongoing participation.

To accomplish this, the initial donation from each Donor Applicant is quarantined until the donor returns for at least a second donation (usually within 2 months) and again demonstrates negative test results in serological testing.

Plasma Pool Testing

Pooling of plasma from donors who have passed all the above steps

All plasma donations from
qualified donors are tested for various viral markers.

Inventory Hold Period

Placement of each qualified donor’s plasma on a 60-day inventory hold

This allows time to see if qualified donors have developed any infections
since they first donated plasma, and, if so, their plasma will be discarded and not used in final processing. The first donation from every donor is discarded unless he or she becomes a qualified repeat donor.

It continues with a state-of-the-art, multi-step manufacturing process to obtain high quality products.

 

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