ArticleEngineering in life sciences2021
Implementation of QbD strategies in the inoculum expansion of a mAb production process.
Article in Engineering in life sciences, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Who cites it
11 citing papers in PubMed, 19 citations in OpenAlex.
- Impact of N-1 phase media optimization as a bioprocess intensification strategy on fed-batch production.Bioprocess and biosystems engineering · 2026Article
- Machine Learning-Powered Optimization of a CHO Cell Cultivation Process.Biotechnology and bioengineering · 2025Article
- Influenza A Virus Production Following Quality by Design Principles.Engineering in life sciences · 2025Article
- A Novel 3D-Printed and Miniaturized Periodic Counter Current Chromatography System for Continuous Purification of Monoclonal Antibodies.Micromachines · 2024Article
- Design space determination to optimize DNA complexation and full capsid formation in transient rAAV manufacturing.Biotechnology and bioengineering · 2023Article
- Employing QbD strategies to assess the impact of cell viability and density on the primary recovery of monoclonal antibodies.Engineering in life sciences · 2023Article
- Optimization of a mAb production process with regard to robustness and product quality using quality by design principles.Engineering in life sciences · 2022Article
- Stress-induced increase of monoclonal antibody production in CHO cells.Engineering in life sciences · 2022Article
- Implementation of QbD strategies in the inoculum expansion of a mAb production process.Engineering in life sciences · 2021Article
- Article
- Optimizing clarification processes in biopharmaceutical manufacturing through quality by design: Strategies, implications, and future prospects.Biotechnology progressReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The quality by design approach was introduced to the biopharmaceutical industry over 15 years ago. This principle is widely implemented in the characterization of monoclonal antibody production processes. Anyway, the early process phase, namely the inoculum expansion, was not yet investigated and characterized for most processes. In order to increase the understanding of early process parameter interactions and their influence on the later production process, a risk assessment followed by a design of experiments approach was conducted. The DoE included the critical parameters methotrexate (MTX) concentration, initial passage viable cell density and passage duration. Multivariate data analysis led to mathematical regression models and the establishment of a designated design space for the studied parameters. It was found that the passage duration as well as the initial viable cell density for each passage during the inoculum expansion have severe effects on the growth rate and viability of the early process phase. Furthermore, the variations during the inoculum expansion directly influenced the production process responses. This carry-over of factor effects highlights the crucial impact of early process failures and the importance of process analysis and control during the first part of mAb production processes.
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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.