ILevAA – Integrating Continuous Production and Purification for Leveraging Recombinant Adeno-Associated Viruses (rAAV) Manufacturing

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Designação do Projeto | Project Name | ILevAA – Integrating Continuous Production and Purification for Leveraging Recombinant Adeno-Associated Viruses (rAAV) Manufacturing

Código do Projeto | Project Code | 2023.15456.PEX

Domínio Científico | Scientific Domain | Ciências da Engenharia e Tecnologias

Entidade beneficiária | Beneficiary Entity | iBET – Instituto de Biologia Experimental e Tecnológica

Data de aprovação | Approval Date | 02.08.2024

Data de início | Starting Date | 01.01.2025

Data de conclusão | Conclusion Date | 31.12.2025

Custo total elegível | Total Eligible Cost | 49.285,31 €

Apoio financeiro público nacional | National Public Financial Support | 49.285,31€

Breve Descrição do Projeto | Brief Project Description |

Recombinant adeno-associated viruses (rAAV) have been the viral vector of choice for an increasingly higher number of gene therapy-related clinical studies, due to their overall success and potential. This trend, combined with the high doses required for treatment, has substantially increased the demand for rAAV, prompting the need for more efficient manufacturing methods.

Most rAAV production processes are still based on batch operation mode, and significant scale-up/out efforts are required to generate enough vectors for therapeutic applications. Process intensification strategies have arisen as the strongest alternatives to traditional manufacturing concepts. These methodologies have proven successful for optimizing production yields of various biologics and are shaping the path of progression of biomanufacturing. Still, when applied for rAAV production and purification, such developments have either been modest or mostly been attained at research level, lacking transition into an actual implementation at manufacturing scale.

Aiming at solving this bottleneck, this project focuses on establishing a process for continuous, integrated production and purification of rAAV.  Intensifying the production process will significantly improve the state-of-the art in rAAV technology towards meeting the desired manufacturing needs. By providing a reliable, scalable, and cost-effective production method, this project may support rapid development and foster further research and innovation in gene therapy manufacturing.