At the Advanced Therapies London 2024 conference, Caroline Peachey of European Pharmaceutical Review sat down with Roberto Formisano, Senior Manager of Process Development at AGC Biologics, to explore the details of technology transfer best practices within the gene therapy and viral vector space. A key focal point of their discussion was the significant challenges many within the advanced therapies space have experience when attemptin technology transfers from developers to CDMOs.
Formisano highlighted the critical timelines associated with such transfers, as customers often require quick progression into their initial clinical trials, typically within a few months. Striking the right balance between manufacturing capacity and meeting these stringent deadlines is the main concern.
For developers seeking to make this process as seamless as possible, Formisano offered valuable advice. He emphasized the advantage of having a well-established process, which significantly eases the transition to GMP manufacturing. However, for those lacking such processes, he mentions AGC Biologics provides tailored platforms for Lentiviral Vector (LVV) and Adeno-Associated Virus (AAV) process development, facilitating a smoother transition.
Looking ahead to 2024, Formisano predicted a shift towards larger scales in Viral Vector production within the Cell and Gene Therapy space. This requires a focus on scalability and cost reduction in manufacturing processes, requiring innovative solutions and strategic ingenuity to address evolving industry needs.
Learn more about our Pronto LVV™ and Bravo AAV™ templated approaches created by our team of experts who have supported four commercial viral vector products, three commercial cell therapies, and more than 30 cell and gene therapy clinical trials across Europe and the United States. Our AAV and LVV platforms include in-network plasmid DNA (pDNA) supplies (high-quality and GMP grade), all major testing performed in-house, and the use of cell factories and fixed bed bioreactor for adherent protocols, wave and stirrer bioreactors for suspension, and much more.
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