Pre Conference Workshops (12th May 2025)Monday, 12 May 2025 - CET/CEST (Cent Europe Summer, GMT+2)

Novartis' commitment to deliver high-quality medicines with enhanced efficiency and reduced costs to patients is reflected in its modular setup for continuous and connected biomanufacturing. Designed to optimize capacity and enable multi-product flexibility with high cost-efficiency, this innovative setup employs technologies for a High-Density Perfused Batch (HDPB) cell culture process, continuous capture chromatography, and connected downstream unit operations. The facilities operate in non-GMP as well as GMP environment with a high level of automation and efficiency, aiming to significantly reduce manufacturing costs.

This talk illustrates Novartis' contributions on continuous processing presenting the achievements and recent advancements like cell line development as well as next generation material usage leading to substantial cost savings by minimizing waste, reducing downtime, and improving resource utilization. It showcases advanced liquid handling and process optimizations approaches. Ensuring consistent product quality and consistency, tools like advanced Process Analytical Technology (PAT) are integrated to closely monitor and control the process. It also highlights Novartis' insights and future goals to boost efficiency and enhance process robustness aiming to stay at the leading edge of the biomanufacturing sector and provide unmatched value and quality to patients globally.

This track addresses the complex challenges and innovations in ensuring viral safety in biopharmaceutical manufacturing. It covers process-specific hurdles in viral clearance, risks associated with raw materials, and scalability issues in shared facilities. Attendees will explore cutting-edge detection technologies like Next-Generation Sequencing (NGS) and rapid viral safety testing, alongside discussions on harmonizing global regulatory expectations and adapting to evolving guidelines for novel therapies. Sessions will highlight safety strategies for cell and gene therapy production, automation and digital tools for real-time monitoring, and advanced facility design to mitigate contamination risks. With case studies and expert panels, the track provides actionable insights into emerging risks, enhanced viral clearance methods, and risk-based approaches for continuous and advanced manufacturing processes.

Speakers Include:

Dana Schreffler, Manager of Viral Safety, Regeneron

Noémie Deneyer, Associate Director, MSAT Analytical Belgium Characterization hub Lead, GSK

Elodie Charbaut Taland, CMC Regulatory Intelligence Associate Director, Merck

• Introduction to Biopharmaceutical Life Cycle.
• Explain what upstream bioprocessing involves: the early stages of production, including cell culture and fermentation.
• Outline the key objectives: generating the desired biological product through cell growth and expression.
• Discuss the selection of cell lines (e.g., CHO cells, microbial cells).
• Introduce bioreactors and their role in providing a controlled environment for cell growth.
• Discuss different types of bioreactors (e.g., stirred-tank, wave, single-use) and their applications.
• Explain the fermentation process and its parameters (e.g., pH, temperature, oxygen levels).
• Explain the importance of culture media in supporting cell growth and productivity.
• Describe the process of scaling up from lab-scale to commercial-scale production.
• Highlight current trends in upstream bioprocessing (e.g., single-use technologies, continuous processing).
• Discuss future directions and innovations in the field.

• Explain what downstream bioprocessing involves: the purification and formulation of the biological product after cell culture and fermentation.
• Outline the key objectives: ensuring product purity, quality, and stability.
• Describe the process of harvesting cells or extracellular products from the bioreactor.
• Explain the methods used for cell separation (e.g., centrifugation, filtration).
• Introduce the main purification methods: chromatography, filtration, and precipitation.
• Describe different types of chromatography (e.g., affinity, ion-exchange, size-exclusion) and their applications.
• Explain the principles and applications of ultrafiltration and diafiltration.

1. Looking Beyond Antibodies: What are the Applications for Advanced Therapies?

2. The Data Issue: How Can We Utilize and Effectively Analyse Data to Move Towards Fully Automated Processes?

3. Future Thinking: Dreaming Big – Where Do We Want to be in the Next 10 Years?

4. Business Case for Continuous Bioprocessing: What Barriers Exist for Implementing Continuous and Intensified Approaches and Do the Benefits Outweigh this?

This track addresses the complex challenges and innovations in ensuring viral safety in biopharmaceutical manufacturing. It covers process-specific hurdles in viral clearance, risks associated with raw materials, and scalability issues in shared facilities. Attendees will explore cutting-edge detection technologies like Next-Generation Sequencing (NGS) and rapid viral safety testing, alongside discussions on harmonizing global regulatory expectations and adapting to evolving guidelines for novel therapies. Sessions will highlight safety strategies for cell and gene therapy production, automation and digital tools for real-time monitoring, and advanced facility design to mitigate contamination risks. With case studies and expert panels, the track provides actionable insights into emerging risks, enhanced viral clearance methods, and risk-based approaches for continuous and advanced manufacturing processes.

Speakers Include:

Dana Schreffler, Manager of Viral Safety, Regeneron

Noémie Deneyer, Associate Director, MSAT Analytical Belgium Characterization hub Lead, GSK

Elodie Charbaut Taland, CMC Regulatory Intelligence Associate Director, Merck

• Briefly explain the growing importance of digitalization, AI, and machine learning in the biopharma industry
• Key Areas of Digitalization
  • Data Management and Integration
  • Automation and Robotics
  • Real-time Monitoring and Analytics
• Applications in Manufacturing and Supply Chain
  • Use of digital twins and AI to optimize manufacturing processes and improve yield.
  • AI-driven real-time monitoring and anomaly detection in production lines
  • Use of AI for demand forecasting, inventory management, and logistics optimization
• Challenges and Considerations
• Case Studies
• Future Trends and Directions.

This track addresses the complex challenges and innovations in ensuring viral safety in biopharmaceutical manufacturing. It covers process-specific hurdles in viral clearance, risks associated with raw materials, and scalability issues in shared facilities. Attendees will explore cutting-edge detection technologies like Next-Generation Sequencing (NGS) and rapid viral safety testing, alongside discussions on harmonizing global regulatory expectations and adapting to evolving guidelines for novel therapies. Sessions will highlight safety strategies for cell and gene therapy production, automation and digital tools for real-time monitoring, and advanced facility design to mitigate contamination risks. With case studies and expert panels, the track provides actionable insights into emerging risks, enhanced viral clearance methods, and risk-based approaches for continuous and advanced manufacturing processes.

Speakers Include:

Dana Schreffler, Manager of Viral Safety, Regeneron

Noémie Deneyer, Associate Director, MSAT Analytical Belgium Characterization hub Lead, GSK

Elodie Charbaut Taland, CMC Regulatory Intelligence Associate Director, Merck

• Understanding emerging therapies: distinctions between cell therapy, gene therapy, etc.
  • Therapeutic potential and current clinical landscape of different emerging therapies, unique challenges and opportunities presented.
  • Differences and similarities from ‘traditional’ biologics:
  • What learnings can we take from traditional modalities to approach novel modalities?
• Understanding the Cell Therapy and Gene Therapy manufacturing processes.
  • Best practices when entering/transitioning into the advanced therapy industry.
  • Leveraging experiences from your background into industry.
• Strategies and approaches to best utilise available technologies in the development & production of emerging therapies.
  • Moving and translating research from academia, to start up, industry, and beyond.
  • Understanding the difference between these, how to transition, pros and cons.
• Lessons and experiences from our panellists.

• The evolution of biopharmaceutical modality
• Analytical methods and their purpose in biopharmaceutical development and manufacturing
• Analytical method development and validation
• Product physicochemical characterization - high-performance liquid chromatography (HPLC), capillary electrophoresis (CE), spectroscopy, imaging, and post-translational modification (PTM)
• Product biological assays - cell-based assays (CBA), enzyme-linked immunosorbent assays (ELISA), and potency assays
• Microbiological contaminants - sterility testing, endotoxin testing, and microbial limits testing
• Process impurity testing - host cell DNA, host cell proteins, chromatography ligand
• Role of quality control (QC) and quality assurance (QA) in biopharma
• Case studies and industry examples
• Latest and future advancements in analytical methods and quality assurance

• What barriers are limiting the uptake of continuous manufacturing and how are these being addressed?

• How can you evaluate which processes require an intensified/continuous approach?

• Should companies commit to continuous for sustainability?

• How are emerging technologies assisting?

• How can you move from batch to continuous?

• Where do we want to be in 5/10 years? How can we get there?

This track addresses the complex challenges and innovations in ensuring viral safety in biopharmaceutical manufacturing. It covers process-specific hurdles in viral clearance, risks associated with raw materials, and scalability issues in shared facilities. Attendees will explore cutting-edge detection technologies like Next-Generation Sequencing (NGS) and rapid viral safety testing, alongside discussions on harmonizing global regulatory expectations and adapting to evolving guidelines for novel therapies. Sessions will highlight safety strategies for cell and gene therapy production, automation and digital tools for real-time monitoring, and advanced facility design to mitigate contamination risks. With case studies and expert panels, the track provides actionable insights into emerging risks, enhanced viral clearance methods, and risk-based approaches for continuous and advanced manufacturing processes.

Speakers Include:

Dana Schreffler, Manager of Viral Safety, Regeneron

Noémie Deneyer, Associate Director, MSAT Analytical Belgium Characterization hub Lead, GSK

Elodie Charbaut Taland, CMC Regulatory Intelligence Associate Director, Merck