Absence of in vitro Procoagulant Activity in Immunoglobulin Preparations due to Activated Coagulation Factors

KARGER

Lugar: Basel; Año: 2015 vol. 42 p. 397 - 397

ackground: Immunoglobulin (IG) products, including intravenous (IVIG) or subcutaneous (SCIG) immunoglobulins are considered safe and effective for medical therapy;however, a sudden and unexpected increase in thromboembolic events (TE) after administration of certain batches of IVIG products has been attributed to the presence of activated coagulation factors, mainly factorXIa. Our aims were to examine the presence of enduring procoagulant activity during the manufacturing process of IGs, with special focus on monitoring factor XIa, and to evaluate the presence of in vitro procoagulant activity attributed to coagulation factors in different lots of IVIG and SCIG. Methods: Samples of different steps of IG purification, 19 lots of IVIG and 9 of SCIG were analyzedand compared with 1 commercial preparation of IVIG and 2 of SCIG, respectively. Factors II, VII, IX, XI and XIa and non-activated partial thromboplastin time (NAPTT) were assayed. Results: The levels of factors II, VII, IX, X and