ArticleAdvances in therapy2019
Development of a Lyophilized Formulation of Pegaspargase and Comparability Versus Liquid Pegaspargase.
Article in Advances in therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed, 8 citations in OpenAlex.
- Phase 2, Multicenter Studies of Pegaspargase in Pediatric Patients With Previously Untreated Acute Lymphoblastic Leukemia in Russia: Comparative Study of Liquid and Lyophilized Pegaspargase and Roll-Over Study of Lyophilized Formulation.Journal of pediatric hematology/oncology · 2026Trial
- Phase 2 multicenter study of pegaspargase in Japanese patients with previously untreated acute lymphoblastic leukemia.International journal of hematology · 2025Trial
- Biochemical and Biophysical Divergences between TwoBiochemistry · 2025Article
- Recent advances in L-Asparaginase enzyme production and formulation development for acrylamide reduction during food processing.Food chemistry: X · 2025Review
Corrections and comments
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Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionPegaspargase, a pegylated asparaginase, is a core component in the treatment of acute lymphoblastic leukemia. Pegaspargase in liquid form has a limited shelf life of 8 months due to depegylation, leading to changes in purity and potency over time. Lyophilization is an approach that can improve the stability of biological drug conjugates.
methodsHere we describe the development of a lyophilized formulation of pegaspargase and present results of a series of tests demonstrating that the lyophilized form has comparable physicochemical properties to the liquid form.
resultsStability tests of critical quality attributes, including purity, potency, aggregates and total free polyethylene glycol, demonstrate that lyophilized pegaspargase remains stable for at least 3 years, with optimum stability achieved with storage under refrigerated conditions (2-8 °C).
conclusionsLyophilization improved the stability of pegaspargase without altering other physicochemical properties, permitting a prolonged shelf life of at least 2 years when stored at 2-8 °C. This may enable greater storage flexibility and allow for better management of pegaspargase.
fundingStudy Sponsor: Baxalta (now part of Takeda). Publication Sponsor: Servier Affaires Médicales.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.