Related Experiment Video
Updated: Oct 12, 2025
Purification and Analytics of a Monoclonal Antibody from Chinese Hamster Ovary Cells Using an Automated Microbioreactor System
Published on: May 1, 2019
Rapid cGMP manufacturing of COVID-19 monoclonal antibody using stable CHO cell pools
Rita Agostinetto1, Mara Rossi1, Jessica Dawson2
1MerckSerono S.p.A, Guidonia di Montecello, Italy.
Abstract:
Therapeutic proteins, including monoclonal antibodies, are typically manufactured using clonally derived, stable host cell lines, since consistent and predictable cell culture performance is highly desirable. However, selecting and preparing banks of stable clones takes considerable time, which inevitably extends overall development timelines for new therapeutics by delaying the start of subsequent activities, such as the scale-up of manufacturing processes. In the context of the coronavirus disease 2019 (COVID-19) pandemic, with its intense pressure for accelerated development strategies, we used a novel transposon-based Leap-In Transposase® system to rapidly generate high-titer stable pools and then used them directly for large scale-manufacturing of an anti-severe acute respiratory syndrome coronavirus 2 monoclonal antibody under cGMP. We performed the safety testing of our non-clonal cell bank, then used it to produce material at a 200L-scale for preclinical safety studies and formulation development work, and thereafter at 2000L scale for supply of material for a Phase 1 clinical trial. Testing demonstrated the comparability of critical product qualities between the two scales and, more importantly, that our final clinical trial product met all pre-set product quality specifications. The above expediated approach provided clinical trial material within 4.5 months, in comparison to 12-14 months for production of clinical trial material via the conventional approach.
Insights
This study rapidly produced clinical trial material for a COVID-19 therapeutic antibody using a novel transposon system. This accelerated approach significantly reduced development timelines compared to traditional methods.
Area of Science:
- Biotechnology
- Biopharmaceutical Manufacturing
- Immunology
Background:
- Traditional therapeutic protein manufacturing relies on stable, clonally derived host cell lines, which are time-consuming to develop.
- Extended timelines for cell line development delay the overall therapeutic manufacturing process.
- The COVID-19 pandemic necessitated accelerated development strategies for new therapeutics.
Purpose of the Study:
- To evaluate a novel transposon-based system for rapid generation of stable cell pools for biopharmaceutical manufacturing.
- To produce an anti-SARS-CoV-2 monoclonal antibody using a non-clonal cell bank for clinical trials.
- To assess the feasibility and efficiency of an expedited manufacturing process.
Main Methods:
- Utilized the Leap-In Transposase® system to generate high-titer stable cell pools.
- Produced an anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) monoclonal antibody under current Good Manufacturing Practices (cGMP).
- Conducted safety testing on the non-clonal cell bank and scaled production from 200L to 2000L.
Main Results:
- Successfully generated stable cell pools and manufactured an anti-SARS-CoV-2 monoclonal antibody.
- Demonstrated comparability of critical product quality attributes between 200L and 2000L scales.
- Produced clinical trial material within 4.5 months, significantly faster than the conventional 12-14 months.
Conclusions:
- The transposon-based system enables rapid generation of stable cell pools for large-scale biomanufacturing.
- This expedited approach significantly shortens therapeutic development timelines, crucial for pandemic response.
- The non-clonal cell bank strategy is viable for producing clinical-grade therapeutic antibodies meeting quality specifications.
