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Updated: Jul 9, 2026
08:14
Characterization of Leukocyte-platelet Rich Fibrin, A Novel Biomaterial
Published on: September 29, 2015
Safety procedures of coagulation factors
1Research & Development Area, Instituto Grifols, S. A., Barcelona, Spain. juanignacio.jorquera@grifols.com
Summary
Plasma derivative safety relies on preventive measures like donor screening and pathogen testing, alongside elimination procedures such as solvent-detergent treatment and nanofiltration. These methods effectively mitigate risks from known and unknown viruses, ensuring product safety.
Area of Science:
- Biotechnology and Pharmaceutical Sciences
- Virology and Infectious Diseases
- Blood Product Safety
Background:
- Biological products, including plasma derivatives, require rigorous safety protocols to prevent pathogen transmission.
- Established preventive measures include donor screening, serological testing, and nucleic acid amplification techniques (NAT) for key viruses like HIV, HBV, and HCV.
- A mandatory inventory hold period further enhances safety by allowing for the exclusion of donations from seroconverting donors.
Purpose of the Study:
- To outline and evaluate the comprehensive safety procedures employed in the manufacturing of plasma derivatives.
- To assess the efficacy of both preventive and elimination strategies in minimizing the risk of viral and prion transmission.
- To highlight advancements in pathogen inactivation technologies and their impact on product safety.
Main Methods:
- Implementation of epidemiological controls and health assessments for donor populations.
- Application of serological and nucleic acid amplification techniques (NAT) for pathogen detection in donations.
- Utilisation of validated viral inactivation/elimination methods, including solvent-detergent treatment, pasteurization, dry-heat, and nanofiltration.
Main Results:
- Solvent-detergent treatment has proven highly effective against enveloped viruses, with no known transmissions since its introduction.
- Dry-heat treatment and nanofiltration demonstrate efficacy in eliminating non-enveloped viruses like HAV and B19.
- While transmissible spongiform encephalopathies (TSEs) are not known to transmit via plasma products, manufacturing processes show significant capacity to eliminate TSE agent models.
Conclusions:
- A multi-layered approach combining preventive and elimination procedures ensures a high level of safety for plasma-derived products.
- Advanced viral inactivation technologies effectively address risks from both known and emerging viral threats.
- Current manufacturing processes provide a substantial safety margin against potential prion contamination, despite the absence of documented cases.
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