Characterization, upscaling and formulation development of a recombinant, engineered variant of anti-leukemic chemotherapeutic drug L-asparaginase

Abstract

According to a SEER (2015) study, 31% of childhood cancers are due to leukemia. One of its subtypes, Acute Lymphoblastic Leukemia, is known to comprise 80-90% of leukemia cases. Of all the therapies available for such patients, chemotherapy has been the most common choice by clinicians. One of the biologics, L-asparaginase has been consistently an important component of the chemotherapeutic regimen administered to such patients. To address some of the limitations/side effects associated with the administration of L-asparaginase, a recombinant enzyme from E. coli has been modified through rational protein engineering (Sonawane et.al.) that has shown promising results after in-vitro and in-vivo studies to minimize such side effects/ limitations. After multiple screening, four mutants designated as Mutants A, B, C and D have been evaluated for their therapeutic efficacy at the clinical set-up.