Advanced Biomanufacturing
Four sessions are available for abstract submissions.
Digital Transformation in Biomanufacturing
Biopharmaceutical manufacturing has recently vigorously embraced digital transformation to maximize productivity and efficiency. Compared to mature platforms such as synthetic medicine manufacturing, complex biological systems present both challenges and opportunities in the digital world. In particular, the breakthrough and unprecedented investment in artificial intelligence enables revolutionary interconnectivity within bioprocess systems. The collective impact of 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 insightful 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
This session will focus on discussions of innovative approaches to biomanufacturing that are implementation-ready or being implemented into GMP manufacturing. The implementation of new technologies often involves overcoming challenges in the scalability, 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 steps towards implementation of the technology in GMP manufacturing and lessons learned from the project. The discussion will cover current technology gaps in manufacturing and opportunities for new technology introductions and solutions developed or co-developed with bioprocess vendors.
Manufacturing Innovations to serve underserved populations
The pandemic helped to highlight the inequitable access to vaccines that exist 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 healthcare solutions is top of mind, thus innovations that contribute to distributed manufacturing (DM) approaches for products are particularly of interest.
Case Studies: Advanced Manufacturing for Novel Modalities
The use of biomolecules as therapeutics has significantly increased over recent years to address unmet medical needs. As more novel and complex biomolecules are introduced and advanced through clinical trials, the technologies and processes supporting the development and manufacturing of these modalities need to adapt to the new challenges that these biotherapeutics convey. In this session, we explore the development of advanced manufacturing technologies for mRNA, oligonucleotides, antibody-drug conjugates (ADCs), AAV, and other nontraditional biotechnology products with the potential to transform patient care. This session will focus on case studies that will describe bioprocess development and manufacturing technology innovations that go beyond simple, linear scale-up of laboratory-scale methods used to support early development. Attendees will gain insights into how to optimize and implement robust and scalable manufacturing processes that are better understood, more efficient, and capable of enhanced process and product quality control. Presentations will also touch upon evolving regulatory and compliance considerations and the translation of these advancements into real-world manufacturing settings.