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Impact of anti-PEG IgM antibodies on the pharmacokinetics of pegylated asparaginase preparations in mice.
Early loss of asparaginase activity as observed in serum of ALL patients is a complex process and cannot be explained solely by the existence of pre-existing anti-PEG antibodies.
Comparative pharmacokinetic/pharmacodynamic characterisation of a new pegylated recombinant E. colil-asparaginase preparation (MC0609) in Beagle dog
The new pegylated recombinant l-asparaginase preparation MC0609 revealed striking differences in PK/PD properties compared with Oncaspar® in rat and dog.
Challenges in the analytical characterization of PEGylated asparaginase
Abstract The development of a biosimilar as defined by the European Medicines Agency and the United States Food and Drug Administration looks attractive from the financial and market perspective.