In a recent video interview, Roberto Formisano, Process Transfer Senior Manager at AGC Biologics, discusses the challenges associated with technology transfer in the cell and gene therapy industry. He highlights the complexities involved in transferring technology from development to GMP manufacturing, as well as from a customer to a contract development and manufacturing organization (CDMO).
Roberto emphasizes the critical timelines that present the biggest challenges in the field of technology transfer. He explains how balancing the number of batches that need to be manufactured is essential to ensuring sufficient and scientifically quality data within these timelines.
During his conversation with EPR editor Caroline Peachey at Terrapin’s Advanced Therapies conference in London on 19 March, Roberto delves into the nuances of technology transfer and its implications for the industry. He shares his insights on the technology and manufacturing trends and priorities that he foresees for the cell and gene therapy industry in 2024.
According to Roberto, one of the biggest challenges in technology transfer is ensuring that data collected during development stage is transferred seamlessly to GMP manufacturing stage without any loss or disruption. This requires careful planning and coordination between different teams involved in development and manufacturing processes. Additionally, there are regulatory requirements that need to be met during this process which adds another layer of complexity to it.
Another challenge is when a customer wants to outsource their technology development and manufacturing processes to a CDMO. In such cases, there needs to be a clear understanding of each other’s expectations, capabilities and limitations before any work can begin. This includes developing clear communication channels, defining roles and responsibilities clearly, establishing quality control measures and ensuring compliance with relevant regulations.
Looking ahead to 2024, Roberto predicts that automation will play a crucial role in improving efficiency and reducing costs in cell and gene therapy manufacturing processes. He also anticipates increased use of single-use equipment for better containment of contaminants during manufacturing processes.
Overall, Roberto emphasizes that effective communication, planning and coordination are key factors for successful technology transfer in cell and gene therapy industry.
