Designing a Viral Reduction System for FDA approval in Fibrin Sutures

McConnaghy, Erin Marie; D'Amore, Brian Richard; Ferreira, Emily Pearl

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Designing a Viral Reduction System for FDA approval in Fibrin Sutures

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To ensure patient safety and gain regulatory approval for a fibrin based suture, viral reduction must be incorporated into the manufacturing process. A process was designed in which, thrombin and fibrinogen were treated at the liquid phase, thrombin was treated with an acid pH alteration and fibrinogen with solvent detergent. Threads were formed and underwent a dry heat procedure. Viral reduction was validated against bacteriophage and quantified using a plaque assay. The viral reduction of the acid pH, solvent detergent and dry heat was greater than 6, 3.6 and greater than 2, respectively. The viral reduction process did not significantly alter the mechanical properties of the sutures. These results demonstrate process efficiency that is likely to gain regulatory approval.

This report represents the work of one or more WPI undergraduate students submitted to the faculty as evidence of completion of a degree requirement. WPI routinely publishes these reports on its website without editorial or peer review.

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