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European Biopharmaceutical Review

Overcoming the Challenges of Large-Scale Plasmid Production

Gene therapy involves inserting a new section of DNA into a patientís 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.

In 2021, WuXi AppTec acquired OXGENE to become part of WuXi Advanced Therapies. Together, we support innovators all the way from discovery Ė including optimised vector design and engineering, through large-scale plasmid manufacture and supply Ė to GMP viral vector and cell therapy manufacture and testing.

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WuXi Advanced Therapies, a global Contract Testing Development and Manufacturing Organisation (CTDMO), is the advanced therapies business unit of WuXi AppTec. OXGENE is a WuXi Advanced Therapies company, based in Oxford, UK. For more information, please visit: www.advancedtherapies.com www.oxgene.com.
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