From people -
for people
Carefully Selected
Donor Centers
Selection of Healthy
Plasma Donors
High Quality
Plasma
Incoming Plasma
Control
Small Plasma
Batches
Virus Inactivation
Good Manufacturing
Practice
Quality Assurance
& Quality Control
Laboratory Batch
Release
Controlled storage
and Shipment
Clinical Evaluation
Pharmacovigilance
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High Quality Plasma
The plasma is collected by automated plasmapheresis or by separation from whole blood donations in compliance with GMP requirements.
The plasma is rapidly frozen to adequately preserve the labile proteins. The cold chain is maintained and monitored during storage and transport of plasma to ensure constant temperature conditions at -20°C or below.
Each donation is tested for markers of infectious diseases (i.e. HIV, HBV, HCV). The test results must be negative.
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