The Biomanufacturing Industry has risen to a number of challenges in supply chain, drug shortages, and global deployment of manufacturing capabilities in connection with the new geopolitical map and current market needs. We have successfully introduced new ways of working and collaborating between industry and regulatory agencies starting with development and clinical trials and ending at the patient’s side. This session will provide examples of ways of working that have proven beneficial for these processes and highlight how we can continue to develop our ways of working and communication channels to further improve the global reach of our products to meet the patient’s needs. Operational readiness and a focus on reducing environmental impact as well as other areas of sustainability are important factors to further this area of production in a responsible way. The work we do now gives us an excellent opportunity to keep those aspects in everything from design for new as well as retrofitted facilities, drug formulation, and logistics solutions.

The biotechnology industry has changed as a result of the pandemic and has accelerated innovation at an unprecedented pace. As we evolve into a new era of biotechnology, the science and future scientific research will pioneer the pathway to cutting-edge technologies, modalities, and patient-centric therapies.   

This collaborative Think Tank panel discussion, sponsored by Women in Pharma ®, will engage all conference attendees in a thought-provoking conversation about the future opportunities for the industry. Designed for everyone, regardless of their level of experience, this session will guide all participants to think of the future from a personal, professional, and industry level: From regulators and industry leaders to young professionals and students, collaboration and engagement between academia, research and development, and industry will be encouraged. All participants will have the opportunity to share new innovative ideas and gain insights to broaden their footprint as they either embark on or continue their pathway in this impactful and exciting industry.

With rapid advancements in data infrastructure and tools, the Biomanufacturing Industry is implementing new technologies and ways of working to accelerate the delivery of complex biotherapeutics to patients. These digital data transformations require connectivity between highly skilled SMEs in facilities design, equipment selection and validation, technology transfer, manufacturing operations, Quality Assurance, and Regulatory Authorities. This session invites case studies demonstrating the details and value of such digital transformations, including program acceleration, advanced data modeling, rapid technology transfer, enhanced operational readiness, and data-enhanced regulatory submissions.

The quality attributes of advanced therapy medicinal products (ATMPs) that correlate with safety and efficacy in patients are determined not only by manufacturing process inputs such as starting and raw materials, but also by how the manufacturing process itself is designed and controlled. To ensure regulatory compliance, the manufacturing process should therefore be developed based on thorough characterization of the ATMP during all stages of process and analytical development; this ensures that the critical quality attributes that correlate with safety and efficacy are identified and that their specifications can be met during routine manufacturing.  This session will include presentations exemplifying design, manufacturing and operation of the commercial manufacturing of medicinal products.

ATMPs and/or C&GT when applied to the world of Research and Development and Data Science require specific approaches compared to its manufacturing counterpart. Due to the small processing volumes, a Scale Out approach is implemented over a Scale Up approach. Unlike Mab therapy that begins from a Working Cell Bank, ATMPs begin with the patient itself and the variability of the starting material is what characterizes the uniqueness behind personalized medicine. The R&D efforts for ATMPs are focused on a five-dimensional framework where the “five R’s” incorporates notions regarding the right target, the right tissue, the right safety, the right patients, and the right commercial potential. This session invites attendees to explore novel and collaborative methods to achieve a consistent robust process in developing a sustainable, scalable manufacturing platform. Improvements in smart manufacturing of ATMPs/C> supported by AI tools, digitalization and data science are key drivers to scientific, technical and operational progress. Coupled with non-invasive sensors for process monitoring along with dynamic contamination control strategies, the pathway from bench scale to market through smart manufacturing of ATMPs becomes a more tangible reality.