Thursday 18th September - Main Conference Day ThreeThursday, 18 September 2025 - ET (Eastern Time, GMT-05:00)

Process intensification is a key strategy to increase the productivity of cell culture systems while reducing footprint and cost. This session will discuss methods such as increased cell density, optimized feeding strategies, and higher perfusion rates. The speaker will highlight examples of successful process intensification in mammalian cell cultures and how this approach can lead to higher product titers and more efficient use of resources.

Automation is rapidly transforming downstream processing by improving reproducibility, reducing labor costs, and accelerating timelines. This talk will focus on the integration of automation technologies in the downstream workflow, from automated chromatography systems to robotic liquid handling and filtration. The speaker will discuss how automated systems enhance productivity, improve process control, and allow for more consistent and scalable processes.

This session will provide insights into the new ICH guidelines on analytical profiles (Q14), including the ATP document, requirements for methods, and the shift to different validation approaches. The talk will cover long-term monitoring, case studies of switching methods or technologies, and how to meet acceptance criteria or update analytical technology.

This session will provide practical advice for bioprocess programs navigating post-approval submissions and late-stage commercialization. A key focus will be post-approval comparability, including strategies for managing situations where materials fall outside of established acceptance criteria. The talk will explore the use of risk assessment.

With AI amd Machine Learning gainig traction in analytics and process control, many companies are still unclear on the actual benefits of implementation. This session critically examines the real-world applications, separating genuine advancements from overhyped claims. Bringing together industry leaders, AI pioneers, and regulatory experts, the session will discuss successes, failures, and where AI is truly delivering value. It will explore successful AI/ML implementations for process optimization, predictive quality control, streamlined data analysis, and the automation of flow cytometry, how AI-driven computational modeling is reshaping biomanufacturing, and the next five years of AI in analytical sciences and QC. Attendees will gain insights into AI’s current applications and future potential, how it redefines quality control, data analysis, and process optimization, and hurdles that need to be overcome.

This session will delve into the complex regulatory landscape surrounding the use of Artificial Intelligence (AI) and Machine Learning (ML) in the development, manufacturing, and quality control of biologics. Experts will discuss evolving guidelines from regulatory agencies, including best practices for validating AI/ML models, ensuring data integrity, and demonstrating the reliability and transparency of AI/ML-driven decisions, panelists will deliver strategies, improvements in processes, and lower costs of operations through the proper application of the data. Key focus areas include strategies for generating trust and confidence in AI/ML-based analytics for regulatory submissions and maintaining compliance throughout the product lifecycle with specific actionable strategies

Scalability is critical to ensure that bioprocesses developed at small scales translate to larger scales without compromising product quality, yield, or consistency in cell growth kinetics. Maintaining key culture conditions, such as nutrient supply, mass transfer, and mixing, is essential for achieving consistent cell growth, metabolic behavior, and viral vector production. This study explores how intensified cell perfusion systems can work hand in hand with cell culture media development to address these challenges. Our focus for this work is on scale-up strategies that ensure reproducible cell growth and viral vector production across different scales in HEK293 cell cultures.

Join us for a session to discover how to:

• Enable optimization of nutrient balance, execute efficient waste management, and achieve consistent and scalable HEK293 cell growth via a specialized HEK293 media perfusion process
• Intensify viral vector production by transiently transfecting cells across various perfusion processes and bioreactors
• Achieve consistent HEK293 cell metabolic profiles in different cell densities, demonstrating a robust and versatile bioprocess with precise control of bioprocess parameters
• Reduce operational costs while enhancing titer yield with the combination of automated control systems and advanced perfusion techniques
  
  

• Integrating in silico models for process development

• Using digital twins and ML to generate predictive results without experiments

• High-throughput screening and model refinement for improved accuracy

The latest trends in biomanufacturing facility design, including the integration of single-use systems and automation to achieve greater flexibility, efficiency, and cost-effectiveness. This session will address how to bridge the gap between islands of automation and fully integrated plants.

This talk could address the increasing demand for biologics and discuss innovative solutions for capacity expansion, including modular facilities, process intensification, and improved resource utilization.

Traditional QC methods often cause bottlenecks due to their slowness, labor intensity, and variability. This session explores cutting-edge automation solutions, high-throughput analytics, and real-time release testing (RTRT) designed to dramatically enhance efficiency and data integrity in biopharmaceutical QC, streamline workflows, and accelerate testing. As gene and cell therapies move to commercial manufacturing, you'll learn how to scale QC processes, ensure assay transferability, and maintain data integrity across production sites. The session will cover implementing RTRT and high-throughput analytics, strategies for harmonizing QC across multiple manufacturing locations, and the rise of plug-and-play analytical tools. Attendees will gain actionable insights for optimizing QC operations, improving process control, ensuring compliance, and reducing risk during commercial expansion. Learn about next-gen QC strategies that increase efficiency, improve consistency, and ensure regulatory compliance while reducing product release bottlenecks.

• How to ensure safety and compliance while accelerating clinical and manufacturing timelines

• Common pitfalls and best practices

• Strategies to address changing regulatory requirements during rapid development

• Strategic approaches to transitioning from clinical development to manufacturing readiness

• Aligning speed with regulatory expectations for product quality and safety

This session will cover the key steps in developing a scalable and efficient downstream process for biologics production. Topics will include translating small-scale laboratory processes to pilot and commercial scales, selecting the appropriate purification techniques, and ensuring robust, reproducible processes that meet regulatory requirements. Case studies will be presented to illustrate the challenges faced during scale-up and how they were overcome.

As biopharmaceutical production scales, the environmental footprint of downstream processing becomes a growing concern. This talk will explore sustainable practices in downstream processing, including waste reduction, energy-efficient processes, and minimizing the use of toxic solvents. Techniques like recyclable chromatography resins, green solvents, and waste stream recycling will be discussed to promote sustainability in the industry.

This talk will address the critical challenges of technology transfer, particularly the data-related bottlenecks that often hinder the scaling of projects from lab to clinical trial and manufacturing. It will explore the role of software solutions in streamlining this process and discuss how modernizing tech transfer practices can improve efficiency, data handling, QA, and overall speed. The presentation will offer practical strategies for overcoming these hurdles and provide insights into what an optimized, modernized tech transfer workflow could entail.

This panel will explore the critical role of CDMOs in modern biomanufacturing, covering topics from partner selection and relationship management to navigating regulatory challenges and optimizing for success in a rapidly changing environment

Discover cutting-edge analytical strategies for characterizing complex next-generation biologics, including LNPs, hypoimmune cell therapies, and CRISPR-based treatments. As cell and gene therapies rapidly evolve, innovative analytical techniques are needed to ensure product quality, accelerate development, and navigate the evolving regulatory landscape. This session explores new tools for characterizing engineered immune cells and gene-edited therapies, the growing role of Next-Generation Sequencing (NGS) and Mass Spectrometry (MS), and the integration of emerging bioanalysis techniques. Attendees will gain actionable insights to tackle the analytical challenges posed by complex biologics and learn about innovations in analytical methodologies for biopharmaceutical characterization, process analytics, and advanced automated peptide synthesis and purification methods