Pharma 4.0 and 5.0 – Implications of AI and Machine Learning Approaches
AI/Machine Learning, Pharma 4.0/5.0, PAT, QbD

This theme explores advances and challenges in using artificial intelligence (AI) and machine learning (ML) in the pharmaceutical industry. Discuss the implementation of AI-based Process Analytical Technology (PAT) and predictive modeling in the development of drugs, highlighting their potential for improving efficiency and accuracy. Address the regulatory interface, emphasizing the role of AI in meeting the requirements and standards of Pharma 4.0/5.0. Focus on the critical aspects of data integrity, auditing, and compliance, both domestically and globally, ensuring transparency and accountability in using AI and ML in pharmaceutical processes.
 

Product Development and Manufacturing Challenges
Continuous Processing and Manufacturing, 3D Printing, Compliance, Regulatory, PAT, QbD, Advanced Analytical Methods, On-demand Manufacturing

Explore the cutting edge of the field of product development and manufacturing and address the need for rapid response to supply chain challenges and global disruptions through innovative approaches such as on-demand manufacturing. Probe the compliance aspects of 3D printing approaches and continuous processing and manufacturing. Explore associated analytical and control approaches, including Process Analytical Technology (PAT) and Quality by Design (QbD), paving the way for improved production efficiency. Additionally, uncover new and advanced analytical approaches for characterization.
 

Novel Pharmaceutical Materials and Processes
Functional Excipients, Supply Chain, Drug Formulation, Long-acting Oral Delivery, Novel Drug Delivery, Packaging

Discover how technology is addressing stability challenges and eliminating cold-chain storage and distribution, as well as improving drug preservation and simplifying the supply chain. Explore the latest advances in functional excipients, unlocking new possibilities for drug formulation and delivery. Learn about the development of manufacturing and control strategies for complex polymer devices intended for long-acting oral delivery, paving the way for improved therapeutic outcomes. Look into the integration of novel excipients into non-sterile manufacturing processes and existing technologies, enhancing drug production efficiency. Explore new technology approaches to difficult dosage forms, such as liquid-filled gelatin capsules, with the potential for novel drug administration. Finally, uncover the transformative impact of packaging and storage technology advancements, ensuring the integrity and quality of pharmaceutical products.

Current Trends in Parenteral Drug Manufacturing

Process Development, Manufacturing Facility, Environmental Monitoring, Process Engineering, Novel Excipients, Lipid Nanoparticles, Supply Chain

Parenteral administration has enabled targeted drug delivery of complex molecules such as proteins and mRNA, as well as small molecules for treating various diseases that need site-specific targeting and to minimize side effects. Developmental considerations such as technologies involving upstream and downstream processes, development of novel delivery modalities like lipid nanoparticles, and designing well-controlled manufacturing facilities have progressed over the course of years to provide the best suited manufacturing processes for various injectable products. Supply chain management plays a pivotal role in ensuring product quality and viability. Discuss current trends in manufacturing parenteral drug products, innovative technologies for delivery systems, downstream processing technologies, and facility design considerations, along with trends and challenges faced by supply-chain management.
 

Tackling the CMC Challenges of New Therapeutic Modalities

New Therapeutic Modalities, Cell and Gene Therapy, Autologous Therapy, Cold Chain Management, Biologics

The curative potential of new therapeutic modalities (such as cell and gene therapy, nucleotide-based therapeutics, and in vivo expressed biologics) has led to an explosion of interest and investment in this space in the past five years. While parallels can be drawn with small molecule drugs and monoclonal antibodies, there are a number of unique and significant challenges for the manufacture of these novel therapeutics. Discuss topics such as new technologies to increase yields, reduce manufacturing costs, and shorten turnaround time, as well as chain of identity and chain of custody for autologous therapies, cold chain management, agile supply chains supporting a resilient ecosystem, accessibility of GMP-grade reagents, and regulatory/compliance expectations.
 

Present and Future of Drug-Device Combination for Sterile Products

Devices, Combination Products, Compliance, Sustainability, Lifecycle Management, Implantable Devices

Focus on the present and future of drug-device combination across all modalities for sterile products such as autoinjectors, connected and smart autoinjectors, both biodurable and bioerodible implantable devices (i.e., intraocular, subcutaneous, intrathecal, etc.), large-volume patch injectors, etc. Discuss the regulatory and compliance aspects, comparative analyses for generic combination products, industrial challenges, product sustainability, lifecycle management, and other technological advances.