Related Experiment Video
Updated: May 7, 2026

Preparation and Pathogen Inactivation of Double Dose Buffy Coat Platelet Products using the INTERCEPT Blood System
Published on: December 7, 2012
Pathogen inactivation and removal methods for plasma-derived clotting factor concentrates
Robert Klamroth1, Albrecht Gröner, Toby L Simon
1Center for Vascular Medicine, Vivantes Klinikum im Friedrichshain, Berlin, Germany.
Ensuring pathogen safety in plasma-derived clotting factors involves rigorous donor screening, donation testing, and integrated viral inactivation/removal manufacturing steps. These measures are vital for preventing infectious agent transmission in patients with bleeding disorders.
Area of Science:
- Hematology
- Virology
- Biotechnology
Background:
- Plasma-derived clotting factor concentrates are essential for treating bleeding disorders like hemophilia.
- Pathogen safety is paramount due to the risk of transmitting blood-borne viruses and prions.
- Historically, hepatitis viruses and HIV posed significant threats to recipients.
Purpose of the Study:
- To review current pathogen inactivation and removal techniques in plasma-derived clotting factor concentrate manufacturing.
- To emphasize the importance of integrated safety measures throughout the production process.
- To discuss strategies for ensuring the safety of plasma-derived therapies.
Main Methods:
- Review of established pathogen safety measures including donor selection and donation screening.
- Analysis of integrated virus inactivation and removal steps in manufacturing processes.
- Discussion of cleaning and sanitization protocols to prevent batch contamination.
Main Results:
- Modern manufacturing processes have significantly reduced the transmission of viruses like hepatitis and HIV.
- Purification steps in factor concentrate production also reduce prion infectivity.
- Combined inactivation/removal steps offer the most robust pathogen safety.
Conclusions:
- Multiple complementary pathogen inactivation and/or removal steps are ideal for ensuring product safety.
- Stringent cleaning and sanitization are critical for preventing cross-contamination.
- Continuous vigilance and advanced manufacturing are key to safe plasma-derived therapies.
More Related Videos
10:32Treatment of Platelet Products with Riboflavin and UV Light: Effectiveness Against High Titer Bacterial Contamination
Published on: August 24, 2015
10:48Isolation and Cryopreservation of Highly Viable Human Peripheral Blood Mononuclear Cells From Whole Blood: A Guide for Beginners
Published on: October 25, 2024
Related Concept Videos
Venous Thrombosis III: Interprofessional Care
Physical Methods for Controlling Microbial Growth: Radiation and Filtration
Clot Retraction and Fibrinolysis
Cleaning, Sterilization, and Disinfection
Cleaning
The cleaning process usually involves using water with detergents or enzymatic cleaner and removing foreign material from objects and surfaces, including organic material such as body fluids or inorganic material like soil. Cleaning is performed before high-level disinfection and sterilization because foreign materials on the cover of the devices interfere with process...
Anticoagulant Drugs: Low-Molecular-Weight Heparins
Coagulation
During the coagulation phase, clotting factors, or procoagulants, play a vital role in initiating and progressing the coagulation cascade. This cascade is a series of reactions...