PI Panel
Plasma Safety

All plasma donors must undergo a pre-donation selection process, including verification of good health, medical history, and risk behavior questions. Serological tests for syphilis, hepatitis B, hepatitis C, and human immunodeficiency virus (HIV), and PCR (Polymerase Chain Reaction) tests for genomes of HIV, HBV, HCV, HAV, and Parvo B19 are performed, along with total plasma protein, and hematocrit/hemoglobin levels.

The Plasma Protein Therapeutics Association (PPTA) has a certification program for plasma centers which holds them to rigorous standards for donor selection and collection center performance. Along with the pre-donation physical, the Industry's International Quality Plasma Program (IQPP) requires drug abuse testing, donor education on high-risk behavior, and residency requirements to maintain a steady and reliable supply of quality plasma and safety measures to reduce the risk of collecting contaminated plasma.

To meet PPTA’s Qualified Donor Standard, potential donors must pass two separate medical screenings and testing for HIV, HBV, and HCV on two different occasions. Only after satisfactory screenings and negative test results does that person become a Qualified Donor. If a donor does not return within six months, that person loses his/her Qualified Donor status and must qualify again. This standard means that plasma from a one-time-only donor (even when all test results are negative) cannot be used for further manufacture.

GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] 10% is a purified intravenous immunoglobulin derived from human plasma.

Plasma is collected at FDA-registered collection centers where many precautions are taken to help ensure high-quality safety of our therapies.

First, steps are taken to ensure that only healthy donors donate plasma, including:

• Evaluation of the donors' medical history
• Specific laboratory tests
• Specific plasma pool tests

In addition, the GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] 10% processing includes steps designed to specifically purify IgG, remove unwanted small molecules, and help remove and inactivate any viruses.

GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] 10% purification steps include diafiltration and chromatographic steps which are designed to remove small molecules, like salts, solvent detergent reagents, or, potentially, drugs from the IgG.

GAMMAGARD LIQUID is made from human plasma. It may carry the risk of transmitting infectious agents, e.g. viruses, and theoretically the Creutzfeldt-Jakob disease (CJD) agent.

Please see the GAMMAGARD LIQUID Important Risk Information link on this page for more detailed risk information and the link to the Prescribing Information for full prescribing details.