Advanced Biomanufacturing
Digital Transformation in Biomanufacturing
Monday 3/18/2024, 8:00 -11:00 AM
Biopharmaceutical manufacturing in recent years has vigorously embraced digital transformation to maximize productivity and efficiency. Comparing to mature platforms such as auto or synthetic medicine manufacturing, complex biological systems present both challenges and opportunities in the digital world. In particular, the breakthrough and unprecedent investment in artificial intelligent are enabling revolutionary interconnectivity within the bioprocess systems. The collective impact from industrial scale digitalization is profound and far-reaching. This session is intended to capture the current progress and future vision in digitalizing the next generation of biomanufacturing. We welcome topics covering advanced bioprocess modeling and monitoring, novel sensors and equipment automation, digital twin and digital control strategy, big data analytics and real-time decision-making, smart operation systems, and digital infrastructures (both software and hardware). We especially encourage provocative discussion regarding how ongoing research in AI and machine learning can evolve biomanufacturing. In addition, we look for examples of digital tech transfer, smart validation and quality compliance, AI-documentation (e.g. ChatGPT) and other digital components for manufacturing support.
Case Studies: Implementation of Advanced Biomanufacturing in GMP
Wednesday 3/20/2024, 2:00 – 5:00 PM
This session will focus on in depth discussions on innovative approaches to biomanufacturing that were successfully implemented into GMP manufacturing. While new technologies are often evaluated in the process development laboratories, use of those technologies at scale, under GMP conditions is less prevalent. The hurdles to implement new technologies in manufacturing include scalability of the technology, compliance and audit trail considerations, and stakeholder buy-in into the risk benefit analysis. The case studies presented in this session will combine the technology development aspect with topics of facility fit, regulatory considerations, and tech transfer. The presentations will describe the implementation of the technology in GMP manufacturing, and lessons learned from the project. Current technology gaps in manufacturing and opportunity for new technology introductions will also be discussed.
Patient Populations in Underserved Communities
Thursday 3/21/2024, 8:00 -11:00 AM
The pandemic helped to highlight the inequitable access to vaccines that exists for patients in underserved communities worldwide based on both local resources and community location. Beyond vaccines, access to diverse therapeutic interventions including small molecule drugs, protein-based biologics like monoclonal antibodies, cell and gene therapies and disease diagnostics of all kinds are seriously limited largely due to the significant costs associated with the legacy manufacturing of these products in high income countries (HICs). The democratization of healthcare for patients in low- and middle-income countries (LMICs) or underserved communities within HICs will require advances in manufacturing, potentially deployable in-region, that cost effectively produce therapies intentionally addressing the specific needs of each community, including storage conditions, ease of use and access, and regionally predominant comorbidities. This session will highlight recent innovative manufacturing technologies that support target product profiles for therapies relevant to underserved populations globally. We welcome abstracts that touch on platform technologies and broadly deployable innovations that could improve patient outcomes through greater accessibility to diverse products through lower costs, increased scale or improved process and/or product simplicity. These manufacturing innovations may include advancements in specific aspects of the production, formulation, delivery or analytical assessments of a therapeutic intervention. Involvement of underserved communities in the creation of their own healthcare solutions is top of mind, thus innovations that contribute to distributed manufacturing (DM) approaches for products are particularly of interest.