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Updated: Aug 10, 2026
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Preparation and Gene Modification of Nonhuman Primate Hematopoietic Stem and Progenitor Cells
Published on: February 15, 2019
A safer plasma supply from remunerated donors--"The Immuno/Community Bio-Resources experiment"
A T Waytes1, H Igel, G Zerlauth
1Baxter Healthcare Corporation, Hyland Immuno, Deerfield, IL, USA.
Developments in Biologicals
|May 4, 2000
Summary
A comprehensive plasma quality program significantly enhances the safety of plasma derivatives. This program, featuring donor screening and PCR testing, achieved exceptionally low residual virus levels for HIV, HBV, and HCV.
Area of Science:
- Biotechnology
- Public Health
- Immunology
Background:
- Plasma safety is critical for manufacturing therapeutic products.
- Previous methods for ensuring plasma safety had limitations.
Purpose of the Study:
- To develop and implement a comprehensive plasma quality program to enhance plasma safety.
- To estimate the residual risk of viral contamination in plasma donations.
Main Methods:
- Implemented four key safety initiatives: plasma center standards, qualified donor program, inventory hold, and PCR testing of plasma pools.
- Utilized a statistical model incorporating donor characteristics and historical virus reactive rates.
- Confirmed estimates through subsequent PCR testing of plasma pools.
Main Results:
- Estimated residual likelihood of undetected donations per million: 0 for HIV, 1.64 for HBV, and 4.68 for HCV.
- These rates were significantly lower than previously reported for both remunerated and volunteer donations.
- PCR testing enabled further removal of positive units, enhancing safety.
Conclusions:
- The developed plasma quality program significantly reduced the risk of viral contamination.
- The combination of low virus load plasma and advanced purification techniques yields the safest plasma derivatives to date.
