ArticlemAbs
Upstream cell culture process characterization and in-process control strategy development at pandemic speed.
Article in mAbs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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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.
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Who cites it
16 citing papers in PubMed, 32 citations in OpenAlex.
- A comprehensive strategy for pandemic preparedness with neutralizing monoclonal antibodies.mAbs · 2025Article
- Stem cell revolution: bridging the gap between research and clinical application.Stem cell research & therapy · 2025Review
- Scale-Up Strategy Focused on Hydrodynamic Stress for Mammalian Cell Culture Established by a Dry-Wet Approach.Engineering in life sciences · 2025Article
- Therapeutic Antibodies for Infectious Diseases: Recent Past, Present, and Future.Biochemistry · 2025Review
- Incorporating shaken 24-deep-well plate fed-batch culture shortens CHO cell line development time.Cytotechnology · 2025Article
- Lifecycle DoE-The Companion for a Holistic Development Process.Bioengineering (Basel, Switzerland) · 2024Article
- Holistic in silico developability assessment of novel classes of small proteins using publicly available sequence-based predictors.Journal of computer-aided molecular design · 2024Article
- Streamlined Multi-Attribute Assessment of an Array of Clinical-Stage Antibodies: Relationship Between Degradation and Stability.Applied spectroscopy · 2024Article
- Further accelerating biologics development from DNA to IND: the journey from COVID-19 to non-COVID-19 programs.Antibody therapeutics · 2024Review
- Temperature Upshifts in Mammalian Cell Culture: A Suitable Strategy for Biosimilar Monoclonal Antibodies?Bioengineering (Basel, Switzerland) · 2023Article
- Monoclonal antibody therapies for COVID-19: lessons learned and implications for the development of future products.Current opinion in biotechnology · 2022Review
- Hybrid modeling for in silico optimization of a dynamic perfusion cell culture process.Biotechnology progressArticle
- A recurrent neural network for soft sensor development using CHO stable pools in fed-batch process for SARS-CoV-2 spike protein production as a vaccine antigen.Biotechnology progressArticle
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Corrections and comments
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Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
As of early 2022, the coronavirus disease 2019 (COVID-19) pandemic remains a substantial global health concern. Different treatments for COVID-19, such as anti-COVID-19 neutralizing monoclonal antibodies (mAbs), have been developed under tight timelines. Not only mAb product and clinical development but also chemistry, manufacturing, and controls (CMC) process development at pandemic speed are required to address this highly unmet patient need. CMC development consists of early- and late-stage process development to ensure sufficient mAb manufacturing yield and consistent product quality for patient safety and efficacy. Here, we report a case study of late-stage cell culture process development at pandemic speed for mAb1 and mAb2 production as a combination therapy for a highly unmet patient treatment. We completed late-stage cell culture process characterization (PC) within approximately 4 months from the cell culture process definition to the initiation of the manufacturing process performance qualification (PPQ) campaign for mAb1 and mAb2, in comparison to a standard one-year PC timeline. Different strategies were presented in detail at different PC steps, i.e., pre-PC risk assessment, scale-down model development and qualification, formal PC experiments, and in-process control strategy development for a successful PPQ campaign that did not sacrifice quality. The strategies we present may be applied to accelerate late-stage process development for other biologics to reduce timelines.
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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.