Cited by 2Monoclonal and Polyclonal Antibodies ResearchProtein purification and stabilityViral Infectious Diseases and Gene Expression in Insects

Current GMP standards for the large‐scale production of monoclonal antibodies

Open access
Troncoso‐Bravo, Tays, Pavez, Valentina, Letelier, Pedro, Del Río, Javier, Anabalón, Cristian, Peñaloza, Hernán F., González, Pablo A., Bueno, Susan M. +1 more·2026·Bioengineering & Translational Medicine

Abstract

Monoclonal antibodies have revolutionized modern medicine due to their target‐specific properties and effectiveness in treating a wide range of diseases, including cancer, autoimmune disorders, infectious diseases, and neurological conditions. Importantly, their large‐scale production for human use requires strict adherence to good manufacturing practice (GMP) standards to ensure quality, safety, and efficacy. This article reviews key aspects of monoclonal antibody production under GMP standards, from cell‐line selection to culture strategies, antibody purification, formulation, and quality control processes. Additionally, we discuss the significance of validation and traceability in production, as well as the implementation of emerging technologies to enhance manufacturing efficiency and safety. Despite progress in bioprocesses and regulatory frameworks, several challenges, such as batch‐to‐batch variability, high production costs, and the need to continuously adapt processes to new regulations, remain to be solved. The integration of innovative approaches with evolving regulations will enable the optimization of monoclonal antibody production and ensure their global accessibility.

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Crossref · 10.1002/btm2.70121

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Research works printed but not linked: 3

  1. [11]Malik B, Ghatol A. Understanding How Monoclonal Antibodies Work. StatPearls Publishing; 2023: 3428348. 34283484
  2. [74]Wiebe ME, May LH. Cell banking. In: Lubiniecki A, ed. Large‐Scale Mammalian Cell Culture Technology. 1st ed. Routledge; 1990.
  3. [105]Marson B, Concentino V, Junkert A, Fachi M, Vilhena R, Pontarolo R. Validation of analytical methods in a pharmaceutical quality system: an overview focused on HPLC methods. Quim Nova. 2020; 43: 1190‐ 1203.

Authors
Troncoso‐Bravo, T., Pavez, V., Letelier, P., Del Río, J., Anabalón, C., Peñaloza, H. F., González, P. A., Bueno, S. M., & Kalergis, A. M.
Affiliations
  • Pontificia Universidad Católica de Chile (CL)
  • Millennium Institute on Immunology and Immunotherapy, Facultad de Ciencias Biológicas Pontificia Universidad Católica de Chile Santiago Chile
  • Universidad de Santiago de Chile (CL)
Corresponding author
Kalergis, Alexis M.
Venue
Bioengineering & Translational Medicine
Publisher
Wiley
Published
2026-02-09
Volume
11
Issue
3
Pages
e70121-e70121
ISSN
2380-6761 (ISSN-L)
OpenAlex
W7128432086
Cited by
2
References
108
Citations by year
2026: 2
FWCI
2.60
Type
journal article
Language
en
Open access
Locations
  • Bioengineering & Translational Medicine (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • PubMed Central (publishedVersion, cc-by)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
Funders
  • Instituto Milenio en Inmunología e Inmunoterapia
  • Bangladesh Medical Research Council (P7)
Topics
  • Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Protein purification and stability
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Viral Infectious Diseases and Gene Expression in Insects
Keywords
monoclonal antibodies, good manufacturing practices, cell line selection, antibody purification, formulation, quality control, process validation, traceability, batch-to-batch variation, production costs

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