Current GMP standards for the large‐scale production of monoclonal antibodies
Open accessAbstract
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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Flagged first, then by citations
Research works printed but not linked: 3
- [11]Malik B, Ghatol A. Understanding How Monoclonal Antibodies Work. StatPearls Publishing; 2023: 3428348. 34283484
- [74]Wiebe ME, May LH. Cell banking. In: Lubiniecki A, ed. Large‐Scale Mammalian Cell Culture Technology. 1st ed. Routledge; 1990.
- [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)
- PMC
- PMC13247427
- OpenAlex
- W7128432086
- Cited by
- 2
- References
- 108
- Citations by year
- 2026: 2
- FWCI
- 2.60
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- 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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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