Challenges in the analytical characterization of PEGylated asparaginase

  title={Challenges in the analytical characterization of PEGylated asparaginase},
  author={Gunda Brandenburg and Sabine Poppenborg and Christoph Radcke and Julia G. Wittmann and Ralf Kr{\"a}hmer and Gianfranco Pasut and Frank Leenders},
2 Citations
Cancer Nanomedicine and Immune System—Interactions and Challenges
The interactions between an approved cancer nanomedicine with TME immunology is reviewed and the challenges that need to be addressed for the full clinical potential of ongoing cancer Nanomedicines despite the encouraging preclinical data are discussed.
Integrated Lab-Scale Process Combining Purification and PEGylation of l-Asparaginase from Zymomonas mobilis
During the last quarter of a century, PEGylation has been used to enhance the clinical effectiveness of various therapeutic proteins. However, the conjugation process significantly increases the co...


The Concept of Biosimilars: From Characterization to Evolution-A Narrative Review.
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Comparative pharmacokinetic studies of three asparaginase preparations.
The apparent t1/2 of ASNase is dependent on enzyme preparation used, but is not affected by dose or by repeated use, and patients who have had a hypersensitivity reaction to E coli ASnase have a decreased apparent t 1/2 with both E coli and PEG AsNase.
Biosimilars: Company Strategies to Capture Value from the Biologics Market
Five core capabilities have been identified as paramount for those companies aiming to enter the biosimilars market: research and development, manufacturing, supporting activities, marketing, and lobbying.
Structure-function relationships and clinical applications of L-asparaginases.
This paper reviews the available biochemical and pharmacokinetic information of the therapeutic forms of bacterial L-ASNases, and focuses on a detailed description of structure, function and clinical applications of these enzymes.
Pharmacokinetics, pharmacodynamics, efficacy, and safety of a new recombinant asparaginase preparation in children with previously untreated acute lymphoblastic leukemia: a randomized phase 2 clinical trial.
It is concluded that the new recombinant asparaginase and other native Asparaginases medac are bioequivalent and have the same pharmacodynamic effects and the same direct toxicity profile in children with acute lymphoblastic leukemia.
Biosimilars in Developed and Developing East and Southeast Asian Countries: Japan, South Korea, and Malaysia—Overview, Evolution, and Regulations Assessment
This paper reviews the literature on biosimilar drugs and covers their therapeutic status, clinical trials, approved biosimilars, and regulatory guidelines in Japan, South Korea, and Malaysia.
Cancer therapy with chemically modified enzymes. I. Antitumor properties of polyethylene glycol-asparaginase conjugates.
The covalent attachment of monomethoxypolyethylene glycol (PEG) to asparaginases from Escherichia coli and Vibrio succinogenes by new coupling methodology produced conjugates that are active, stable,