A scoping review to compare and contrast quality assurance aspects of L-asparaginase biosimilars

Xianwei Qin; Tales A. Costa-Silva; Adalberto Pessoa; Paul F. Long

doi:10.1016/j.ijpharm.2022.122523

A scoping review to compare and contrast quality assurance aspects of L-asparaginase biosimilars

Xianwei Qin, Tales A. Costa-Silva, Adalberto Pessoa, Paul F. Long^*

^*Corresponding author for this work

Institute of Pharmaceutical Science

Research output: Contribution to journal › Review article › peer-review

1 Citation (Scopus)

Abstract

L-asparaginase is a first-line medicine used for the treatment of acute lymphoblastic leukemia. Differing quality of marketed L-asparaginase biosimilars has been reported to adversely influence treatment outcomes. Herein, the quality of L-asparaginase biosimilars intended for clinical use was reviewed in sight of quality assurance parameters using English and Chinese language database searching, which provided information for possible improvements to the manufacture of this medicine. Ten articles met inclusion criteria, and quality attributes that measured potency, specific activity, purity and host cell proteins (HCPs) were identified. Biosimilars manufactured in high-income countries represented good quality in all aspects. Biosimilars manufactured in high-middle/middle-income countries, however, suggested poorer quality control particularly over removal of HCPs. Future work should now focus on establishing pharmacopeia monographs to establish equivalent quality assurance for L-asparaginase biosimilars manufactured between countries. Standardization of the quality profile, analytical methods and the limits of critical quality parameters, are essential to ensure appropriated efficacy and safety of clinical grade L-asparaginase.

Original language	English
Article number	122523
Journal	INTERNATIONAL JOURNAL OF PHARMACEUTICS
Volume	632
DOIs	https://doi.org/10.1016/j.ijpharm.2022.122523
Publication status	Published - 5 Feb 2023

Keywords

Acute lymphoblastic leukemia
L-asparaginase
Quality attributes
Quality control
Scoping review

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1016/j.ijpharm.2022.122523

Cite this

@article{c0d260a6fdb54bc7a3b9c35ff345e1f9,

title = "A scoping review to compare and contrast quality assurance aspects of L-asparaginase biosimilars",

abstract = "L-asparaginase is a first-line medicine used for the treatment of acute lymphoblastic leukemia. Differing quality of marketed L-asparaginase biosimilars has been reported to adversely influence treatment outcomes. Herein, the quality of L-asparaginase biosimilars intended for clinical use was reviewed in sight of quality assurance parameters using English and Chinese language database searching, which provided information for possible improvements to the manufacture of this medicine. Ten articles met inclusion criteria, and quality attributes that measured potency, specific activity, purity and host cell proteins (HCPs) were identified. Biosimilars manufactured in high-income countries represented good quality in all aspects. Biosimilars manufactured in high-middle/middle-income countries, however, suggested poorer quality control particularly over removal of HCPs. Future work should now focus on establishing pharmacopeia monographs to establish equivalent quality assurance for L-asparaginase biosimilars manufactured between countries. Standardization of the quality profile, analytical methods and the limits of critical quality parameters, are essential to ensure appropriated efficacy and safety of clinical grade L-asparaginase.",

keywords = "Acute lymphoblastic leukemia, L-asparaginase, Quality attributes, Quality control, Scoping review",

author = "Xianwei Qin and Costa-Silva, {Tales A.} and Adalberto Pessoa and Long, {Paul F.}",

note = "Publisher Copyright: {\textcopyright} 2022 The Author(s)",

year = "2023",

month = feb,

day = "5",

doi = "10.1016/j.ijpharm.2022.122523",

language = "English",

volume = "632",

journal = "INTERNATIONAL JOURNAL OF PHARMACEUTICS",

issn = "0378-5173",

publisher = "Elsevier",

}

TY - JOUR

T1 - A scoping review to compare and contrast quality assurance aspects of L-asparaginase biosimilars

AU - Qin, Xianwei

AU - Costa-Silva, Tales A.

AU - Pessoa, Adalberto

AU - Long, Paul F.

PY - 2023/2/5

Y1 - 2023/2/5

N2 - L-asparaginase is a first-line medicine used for the treatment of acute lymphoblastic leukemia. Differing quality of marketed L-asparaginase biosimilars has been reported to adversely influence treatment outcomes. Herein, the quality of L-asparaginase biosimilars intended for clinical use was reviewed in sight of quality assurance parameters using English and Chinese language database searching, which provided information for possible improvements to the manufacture of this medicine. Ten articles met inclusion criteria, and quality attributes that measured potency, specific activity, purity and host cell proteins (HCPs) were identified. Biosimilars manufactured in high-income countries represented good quality in all aspects. Biosimilars manufactured in high-middle/middle-income countries, however, suggested poorer quality control particularly over removal of HCPs. Future work should now focus on establishing pharmacopeia monographs to establish equivalent quality assurance for L-asparaginase biosimilars manufactured between countries. Standardization of the quality profile, analytical methods and the limits of critical quality parameters, are essential to ensure appropriated efficacy and safety of clinical grade L-asparaginase.

AB - L-asparaginase is a first-line medicine used for the treatment of acute lymphoblastic leukemia. Differing quality of marketed L-asparaginase biosimilars has been reported to adversely influence treatment outcomes. Herein, the quality of L-asparaginase biosimilars intended for clinical use was reviewed in sight of quality assurance parameters using English and Chinese language database searching, which provided information for possible improvements to the manufacture of this medicine. Ten articles met inclusion criteria, and quality attributes that measured potency, specific activity, purity and host cell proteins (HCPs) were identified. Biosimilars manufactured in high-income countries represented good quality in all aspects. Biosimilars manufactured in high-middle/middle-income countries, however, suggested poorer quality control particularly over removal of HCPs. Future work should now focus on establishing pharmacopeia monographs to establish equivalent quality assurance for L-asparaginase biosimilars manufactured between countries. Standardization of the quality profile, analytical methods and the limits of critical quality parameters, are essential to ensure appropriated efficacy and safety of clinical grade L-asparaginase.

KW - Acute lymphoblastic leukemia

KW - L-asparaginase

KW - Quality attributes

KW - Quality control

KW - Scoping review

UR - http://www.scopus.com/inward/record.url?scp=85146126254&partnerID=8YFLogxK

U2 - 10.1016/j.ijpharm.2022.122523

DO - 10.1016/j.ijpharm.2022.122523

M3 - Review article

C2 - 36581108

AN - SCOPUS:85146126254

SN - 0378-5173

VL - 632

JO - INTERNATIONAL JOURNAL OF PHARMACEUTICS

JF - INTERNATIONAL JOURNAL OF PHARMACEUTICS

M1 - 122523

ER -

A scoping review to compare and contrast quality assurance aspects of L-asparaginase biosimilars

Abstract

Keywords

UN SDGs

Access to Document

Other files and links

Fingerprint

Cite this