Health Care : Current Reviews

Kedrion Biopharma, Italy

Publications

• Short Communication   
  Plasminogen drug product stability study for intended use in ligneous conjunctivitis
  Author(s): Alfonso Salvatore, Alessandro Carluccia, Marialetizia Carforaa, Zelinda Raiaa,, Chiara Orazzoa, Valentina Maielloa, Marcella Maddalunoa, Renato Marinielloa, Luca Sanguignoa, Ciro Battagliaa, Roberto Creaa, Roberto Creaa, Marta Bellinia, Anna Falboa and Ester Ascionea
  
  Background: Ligneous conjunctivitis is rare pathology associated to congenital Type 1 plasminogen deficiency. It is characterized by the formation of fibrin rich pseudomebranes. A Plasminogen-based drug has been manufactured by Kedrion biopharma and delivered to patients as compassionate use, showing its efficacy in regression and recurrence prevention of pseudomembranes. The plasminogen drug product is currently stored at <-20°C. Alternative storage conditions for patient use were investigated to establish drug product stability after thawing. Study Design and Methods: The analyzed storage conditions were: the Refrigerator (2-8°C), room temperature (RT, 20-25°C) and high temperature (40°C). 108 Vials of Drug were thawed at RT and divided into three groups to perform three independent studies. 36 vials for each group we.. View more»
  

  Abstract PDF