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Generation and Culture of Blood Outgrowth Endothelial Cells from Human Peripheral Blood
Published on: December 23, 2015
Clinical perspectives of emerging pathogens in bleeding disorders
Christopher A Ludlam1, William G Powderly, Samuel Bozzette
1University of Edinburgh, Edinburgh, UK. Christopher.Ludlam@ed.ac.uk
Lancet (London, England)
|January 24, 2006
Summary
Plasma-derived coagulation-factor concentrates (CFC) are safe from known viruses. However, emerging pathogens and manufacturing processes present ongoing infectious risks, driving the development of safer recombinant alternatives.
Area of Science:
- Hematology
- Virology
- Biotechnology
Background:
- Plasma-derived coagulation-factor concentrates (CFC) undergo rigorous screening and viral reduction, ensuring safety against numerous known transfusion-transmissible viruses like HBV, HCV, HIV, and HTLV.
- Despite advancements, emerging pathogens, especially non-lipid-coated viruses with blood-borne stages resistant to inactivation, pose potential future threats to plasma-derived products.
Purpose of the Study:
- To review the safety of plasma-derived CFC concerning known and emerging infectious agents.
- To discuss the challenges posed by zoonotic transmission and viral evolution to plasma product safety.
- To highlight the development and benefits of recombinant coagulation-factor concentrates (rCFC) as a safer alternative.
Main Methods:
- Review of current screening and viral reduction processes for plasma donations.
- Analysis of the characteristics of emerging pathogens and their potential impact on plasma-derived products.
- Evaluation of the safety profile and manufacturing advantages of recombinant products.
Main Results:
- Current CFC are considered safe from a wide range of established viral threats due to advanced manufacturing and screening.
- Emerging infectious agents and inherent biological variability present persistent challenges to the long-term safety of plasma-derived therapies.
- Recombinant coagulation-factor concentrates (rCFC) offer enhanced safety by eliminating the need for human plasma in production and utilizing entirely non-human-derived reagents.
Conclusions:
- While plasma-derived CFC have achieved a high safety standard, continuous vigilance is necessary due to evolving infectious risks.
- Recombinant technology represents a significant advancement in ensuring the safety and reliability of coagulation factor therapies.
- The shift towards recombinant products mitigates risks associated with human plasma sourcing and viral contamination, enhancing patient safety.
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