Academic Journal
Rapid cGMP manufacturing of COVID‐19 monoclonal antibody using stable CHO cell pools
| العنوان: | Rapid cGMP manufacturing of COVID‐19 monoclonal antibody using stable CHO cell pools |
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| المؤلفون: | Agostinetto, Rita, Rossi, Mara, Dawson, Jessica, Lim, Angela, Simoneau, Mirva H., Boucher, Cyril, Valldorf, Bernhard, Ross‐Gillespie, Adin, Jardine, Joseph G., Sok, Devin, Burton, Dennis R., Hassell, Thomas, Broly, Hervé, Palinsky, Wolf, Dupraz, Philippe, Feinberg, Mark, Dey, Antu K. |
| المصدر: | Biotechnology and Bioengineering ; volume 119, issue 2, page 663-666 ; ISSN 0006-3592 1097-0290 |
| بيانات النشر: | Wiley |
| سنة النشر: | 2021 |
| المجموعة: | Wiley Online Library (Open Access Articles via Crossref) |
| الوصف: | 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. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1002/bit.27995 |
| الاتاحة: | http://dx.doi.org/10.1002/bit.27995 https://onlinelibrary.wiley.com/doi/pdf/10.1002/bit.27995 https://onlinelibrary.wiley.com/doi/full-xml/10.1002/bit.27995 |
| Rights: | http://onlinelibrary.wiley.com/termsAndConditions#vor |
| رقم الانضمام: | edsbas.3E679331 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1002/bit.27995 |
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