DECEMBER 2024LIFE SCIENCES REVIEW 19combines digital simulations and real-world experiments to create custom-tailored developments.Sustainability is another critical challenge, with increasing customer demands for greener processes. Nonetheless, we're actively redesigning processes to foster sustainability and facilitate cost-competitive second-generation processes.How does your organization navigate the regulatory landscape to ensure compliance and safety during the process development?Process safety is inherently integrated into process development at Siegfried. We conduct process safety investigations throughout the development process, employing techniques like differential scanning calorimetry and using reactor calorimeters to assess the behaviour and criticality of our processes. This early assessment helps identify potential safety issues and make necessary adjustments. Furthermore, we employ simulation tools to enhance safety. We also apply process analytical technologies (PAT) to design, analyze, and control our pharmaceutical manufacturing processes.Are there any emerging technologies that you believe will play a significant role in shaping the future of process development?While not entirely new, emerging technologies like flow chemistry and continuous processing, especially in downstream activities, are poised to reshape the future of process development. Batch distillation or batch extractions are lacking in the pharmaceutical industry, and there is potential for significant improvement. We're also exploring ultrafiltration and nanofiltration techniques.Additionally, we're focused on integrating Process Analytical Technologies (PAT) on a larger scale to gain real-time insights and make data-driven decisions, improving process control. Simulation tools for crystallization and other processes are also becoming more sophisticated and valuable in process development.Do you have any advice for other senior leaders and CMOs in the industry?My advice for senior leaders in the industry and CMOs is to have confidence in your capabilities and expertise. In the face of tight schedules, it's essential to recognize your strengths and know what you can handle. Build expertise within your organization and embrace new ideas and technologies, even if they require effort to implement, as these innovations can lead to significant improvements in quality, efficiency, and sustainability. Being self-confident and proactive in offering innovative solutions can set you apart and provide substantial benefits to the industry and customers. We face a significant challenge in process development due to the need to shorten project timelines. This has put immense pressure on us to deliver high-quality work within tighter schedulesThis article is based on an interview between Life Sciences Review and Thomas Carl.
< Page 9 | Page 11 >