Quantitative Risk Evaluation of Adventitious Agents in Heparin.

Autor: Raedts J; Aspen Oss B.V., Oss, The Netherlands., Kellenbach E; Aspen Oss B.V., Oss, The Netherlands.
Jazyk: angličtina
Zdroj: TH open : companion journal to thrombosis and haemostasis [TH Open] 2023 May 21; Vol. 7 (2), pp. e128-e132. Date of Electronic Publication: 2023 May 21 (Print Publication: 2023).
DOI: 10.1055/s-0043-1768946
Abstrakt: Heparin is typically extracted from domestic pigs, which may carry zoonotic adventitious agents. Prion and viral safety cannot be assured by testing the active pharmaceutical ingredient itself; instead for the evaluation of the adventitious agent (i.e., viruses/prions) safety of heparin and heparinoid (e.g., Orgaran or Sulodexide) therapeutics, a risk assessment is required. An approach is presented which provides a quantitative estimation of the worst-case potential residual adventitious agent (i.e., GC/mL or ID 50 ) present in a maximum daily dose of heparin. This estimation is based on the input (determined by prevalence, titer, and amount of starting material to prepare a maximum daily dose) and validated reduction by the manufacturing process, resulting in an estimation of the worst-case potential level of adventitious agent present in a maximum daily dose. The merits of this quantitative, worst-case approach are evaluated. The approach described in this review provides a tool for a quantitative risk evaluation of the viral and prion safety of heparin.
Competing Interests: Conflict of Interest Both authors hold positions in an enterprise which commercially manufactures heparin.
(The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. ( https://creativecommons.org/licenses/by/4.0/ ).)
Databáze: MEDLINE
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