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25 May 2022

Overcoming the Challenges of Large Scale Plasmid Production - EBR


Sponsored/European Biopharmaceutical Review /25 May 2022

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Gene therapy is one of the most exciting fields of biopharma today, but plasmids pose serious challenges for innovation and drug development. WuXi’s acquisition of OXGENE means a fusion of expertise, helping to create an efficient means of developing plasmids on a large scale.

Gene therapy involves inserting a new section of DNA into a patient’s cells. This DNA is delivered by viral vectors, which are usually built from plasmids. Plasmids are small sections of genetic material that can be combined to contain all the genes necessary to deliver the gene therapy. Many challenges associated with manufacturing therapies on a large scale are caused by difficulties when working with plasmids. When manufacturing a plasmid, the final product must be consistent across batches and must not have altered genetic material or other variations that affect quality. Often, small-scale manufacturing processes using adherent cells require significant expertise and process optimisation to adapt to suspension culture for clinical or commercial use (1). There are also regulatory and timescale challenges associated with plasmid production which delay drug development.

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