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About
Plasma
IVIG therapy like GAMMAGARD LIQUID
[Immune Globulin Intravenous (Human)] 10% is made from human
source 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.
Donated plasma is used to make IGIV therapy like GAMMAGARD LIQUID.
People who take IVIG therapy usually take it for their whole
life. Because of this, the purity of their IGIV therapy is extremely
important. To ensure the highest level of purity, GAMMAGARD
LIQUID has a state-of-the-art quality assurance process.
It starts with a rigorous screening and donation
process.
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Use of the National Donor Deferral
Registry (NDDR)
The NDDR is a computerized safety network
that enables all new plasma donors to be crosschecked
with a nationwide list of permanently deferred donors.
GAMMAGARD LIQUID only accepts plasma for processing that
passes the NDDR safety check. |
Collection of source plasma
from qualified repeat donors
Before being qualified, each donor must
pass two consecutive health history exams and two consecutive
viral screenings by giving two donations within 6 months.
Only after completing all these rigorous steps are donors
qualified, and only then is their plasma considered for
use in processing. |
Pooling of plasma from donors
who have passed all the above steps
All plasma donations from
qualified donors are tested for various viral markers. |
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
process to maximize purity and safety
Once all the plasma is tested and approved for processing, each
plasma pool is put through
several purity and safety steps:
| Cohn-Oncley
fractionation |
Solvent/Detergent
treatment |
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This is
a well-established and reliable method for separating
the IgG, the main component of GAMMAGARD LIQUID, from
the other components of plasma. Although the result of
this step is relatively pure IgG, further steps are used
to enhance purity and safety. |
This process inactivates lipid-enveloped viruses.
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Ion-exchange
column
chromatography and diafiltration |
Anion-exchange
column
chromatography purification |
Stabilization |
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This step
removes the solvent, detergents, and dissolved lipid-enveloped
virus components of the solvent/detergent process. |
This process
essentially removes all remaining non-IgG components. The
result is extremely pure IgG. |
During this
step, the purified IgG formulation is stabilized without
sucrose to preserve antibody activity during the remainder
of the process. |
| Freeze
drying |
Final
release |
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After sterile
filtration, the stabilized formulation is dispensed into
vials and freeze-dried. |
The final
step is the release of the product after it has met the
regulatory requirements of current Good Manufacturing Practices
(cGMP). |
As with all plasma-derived therapeutics, the potential to transmit
infectious agents cannot be totally eliminated.
Glossary Terms:
Platelets: Small cell fragments
in the blood that attach to damaged blood vessels and facilitate
clotting.
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