Technology Digest: immunoassay automation is driving advancements in cell and gene therapies

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Reaping the benefits of immunoassay automation

The advancement of CGT is driven by process improvements and technological innovations resulting in faster R&D, improved manufacturability, and more rigorous quality control. New automated platforms, such as the Ella™ platform, provide improved assay sensitivity and reproducibility while addressing issues of workflow and ease of use. CGT developers are leveraging these new automated immunoassay solutions to quickly and reliably quantitate viral vectors, characterize cultured immune cells, and investigate immune response [1].

Immunoassay platforms are valuable as they generate high quality data for chemistry, manufacturing, and control (CMC) and final product manufacturing. Key aspects to consider when choosing a platform include automation, scalability, method transferability and sample volume [1]. To deliver reliable results, it is important to use a high-quality platform. Automated immunoassay platforms from ProteinSimple, such as the Ella™ platform, can eliminate the hands-on steps that come with traditional immunoassays. By this, it reduces human error and increases result collection time [1,4].

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This eBook includes:

  • OPINION: Immunoassay automation is driving advancements in cell and gene therapies
  • REVIEW: Challenges and opportunities in bioanalytical support for gene therapy medicinal product development
  • INTERVIEW: Automated immunoassays are fast tracking cell and gene therapy workflows
  • PERSPECTIVE: Automated immunoassay equipment platforms for analytical support of pharmaceutical and biopharmaceutical development
  • PERSPECTIVE: Bioanalysis of adeno-associated virus gene therapy therapeutics: regulatory expectations

 
 
 

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References

  1. ProteinSimple. eBook: Next-Generation Analytical Solutions for Cell & Gene Therapy. (2020): https://info.proteinsimple.com/next-generation-analytical-solutions-cell-and-gene-therapy.html
  2. Marshall D, Sharpe M & Ward S. Cell & gene therapies and the evolving role of personalized medicine. Cell Gene Ther. Insights, 2(2), 277−286 (2016). https://insights.bio/cell-and-gene-therapy-insights/journal/article/506/Cell-gene-therapies-and-the-evolving-role-of-personalized-medicine
  3. Ma M, Balasubramanian N, Dodge R & Zhang Y. Challenges and opportunities in bioanalytical support for gene therapy medicinal product development. Bioanalysis, 9(18), 1423−1430 (2017). https://www.future-science.com/doi/10.4155/bio-2017-0116
  4. ProteinSimple. Fast and reproducible adeno-associated virus 2 vector quantification with simple plex assays on Ella™. (2021): https://www.proteinsimple.com/documents/AN_Fast-and-Reproducible-AAV2_STRY0156312.pdf

This feature has been brought to you in association with Bio-Techne. The opinions expressed in this feature are those of the author and do not necessarily reflect the views of Bioanalysis Zone or Future Science Group. 

 

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