Humanized monoclonal antibodies Synagis

Schenermann, M.A., Hope, J.N., Kletke, C., Singh, J.K., Kimura, R., Tsao, E. I., Eolena-Wassermann, G., Comparability testing of a humanized monoclonal antibody, Synagis, to support cell line stability, process validation, and scale-up for manufacturing. Biologicals 1999, 27, 203-215. 

Synagis, a humanized monoclonal antibody, consists of several glycoforms. This indicates that a certain degree of microheterogeneity would be acceptable by the FDA. 

Respiratory syncytial virus (RSV) infection represents a major cause of pediatric respiratory hospitalizations. RSV is the most common cause of lower respiratory tract infection in infants. Palivizumab (Synagis) is a humanized monoclonal antibody to the fusion protein of RSV, and is active in animal models for prevention of pulmonary RSV replication [241]. Based on a phase I/II multicenter, randomized, double-blind, placebo-controlled, dose escalation trial by Subramanian et al. in premature infants or infants with bronchopulmonary dysplasia, it was found that the mean half-life of 20 days was comparable with that of other immunoglobulin G preparations. Mean trough serum concentrations 30 days after infusion were 6.8, 36.1, and 60.6pg/mL for the 3-, 10-, and 15-mg/kg dose groups, respectively. Mean serum concentrations of palivizumab that have been shown to produce a 2-log reduction in pulmonary RSV titer in cotton rats were maintained when 10- or 15-mg/kg palivizumab was given every 30 days to pediatric patients at high risk... 

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