Design, Transfer and Qualification of a Commercially-Scalable Process for Viral Vectors

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"Advanced Therapies have come of age. The spectacular clinical results demonstrated by novel gene-engineered T-cell therapies, with subsequent regulatory approvals in the US, have confirmed the commercial reality of a new class of therapeutics that offer real hope to patients who are bereft of effective treatment options. But behind this hope lies a deep concern that high cost-of-goods and problematical scalability will severely limit patient access to these therapies.A critical component of these therapies is a recombinant viral vector capable of effectively transducing the T-cells and enabling the expression of novel anti-tumour receptors. Unfortunately, the current technologies to manufacture these vectors at commercial scales are not fit for purpose. This project will combine leading academic expertise and the commercial imperative of a UK Biotech company to create innovative and scalable viral vector processes that will facilitate patient access to Advanced Therapies."