Gene therapy fill-finish: Critical factors for technical success and smooth CMO collaborations

In recent years, the pharmaceutical industry has been witness to a rapid transformation. By addressing the root causes of diseases rather than just alleviating symptoms, cell and gene therapies (CGTs) are poised to make an unprecedented impact on healthcare, offering hope for patients suffering from complex diseases, including various genetic disorders and cancers, for the first time. 

Starting with the approval of the first autologous dendritic cell therapy in 20101 and followed by other significant advancements such as CAR-T therapies in 20172, it’s important to note that these therapies were not merely incremental improvements but a paradigm shift in the treatment of previously incurable conditions. 

However, this evolution in medicine comes with its own set of challenges, including high development costs, clinical trial risks and reimbursement pressures that could hinder widespread adoption. Nevertheless, the potential for CGTs to not only improve individual health outcomes but also reduce long-term healthcare costs, positions them as a focal point for investment and research within the industry. 

This whitepaper provides an overview of the current state of the gene therapy market, followed by the technical challenges and critical success factors involved in fill-finish – a crucial step in the manufacture and route of administration of gene therapies. As the industry seeks to establish the infrastructure capable of supporting the upcoming growth of the gene therapy market, we will also highlight the importance of strong collaboration with CMOs for ensuring success. 

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Gene therapy fill finish

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