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Background <p>The use of non-clonal CHO cell derived materials for preclinical studies has been found to be a valuable approach to accelerate the development of monoclonal antibodies (mAbs) for first-in-human (FIH) studies. In a comprehensive study, we assessed the culture performance, productivity, and product quality of non-clonal cell lines compared with clonal cell lines expressing various biologic modalities to determine if this approach can be applied to complex molecules.</p> Results <p>We evaluated a multi-specific antibody, a cytokine-Fc fusion protein, and a mAb produced using the stable pool, the pool of top clones, and the lead clone utilizing transposase-mediated integration. The results indicated that the attributes were comparable regardless of the source of cells. Building upon these findings, the study progressed to the preclinical manufacturing of two multi-specific antibodies using both the pool of top clones and the lead clone. Subsequently, clinical manufacturing of these multi-specific antibodies was performed using the lead clone. The batches produced with the pool of clones and the lead clone demonstrated a high level of comparability in culture performance, productivity, and product quality.</p> Conclusions <p>In conclusion, non-clonal CHO cell derived materials can be effectively utilized for preclinical studies of complex molecules without compromising their quality, allowing for accelerated development for FIH studies.</p>

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Utilizing non-clonal CHO cell derived materials for preclinical studies of complex molecules

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年5月7日

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  • Jessica Pan,
  • Jeffrey McPhee,
  • Alex Dow,
  • Daniel Burke,
  • Balrina Gupta,
  • Patricia Rose,
  • Xiaowen Wang,
  • Nuno Pinto,
  • Simon Letarte,
  • Ying Huang,
  • Guanghua Benson Li,
  • Kitty Agarwal,
  • Katelyn Smith,
  • Ren Liu

摘要

Background

The use of non-clonal CHO cell derived materials for preclinical studies has been found to be a valuable approach to accelerate the development of monoclonal antibodies (mAbs) for first-in-human (FIH) studies. In a comprehensive study, we assessed the culture performance, productivity, and product quality of non-clonal cell lines compared with clonal cell lines expressing various biologic modalities to determine if this approach can be applied to complex molecules.

Results

We evaluated a multi-specific antibody, a cytokine-Fc fusion protein, and a mAb produced using the stable pool, the pool of top clones, and the lead clone utilizing transposase-mediated integration. The results indicated that the attributes were comparable regardless of the source of cells. Building upon these findings, the study progressed to the preclinical manufacturing of two multi-specific antibodies using both the pool of top clones and the lead clone. Subsequently, clinical manufacturing of these multi-specific antibodies was performed using the lead clone. The batches produced with the pool of clones and the lead clone demonstrated a high level of comparability in culture performance, productivity, and product quality.

Conclusions

In conclusion, non-clonal CHO cell derived materials can be effectively utilized for preclinical studies of complex molecules without compromising their quality, allowing for accelerated development for FIH studies.