Innovation in bioprocessing means rethinking workflows, adopting advanced technologies, and enabling cross-disciplinary collaboration.

• Advanced technologies: AI/ML and predictive analytics for tighter process control, better scalability, and less variability.
• Faster development: shorten time-to-market for First-in-Human trials with new technologies and workflows
• Optimized manufacturing: novel upstream/downstream approaches to increase yield, lower costs, and improve quality.
• Cross-disciplinary collaboration: scientists, engineers, and regulators working together on holistic solutions.

Dive into sessions that redefine cell line development, streamline upstream and downstream processes, and harness the power of AI, machine learning, and data-driven manufacturing.

Cost optimization is not just about cutting expenses; it is about creating sustainable processes that deliver high-quality therapies efficiently and affordably.

• Efficiency: Streamlining operations to reduce waste, improve resource utilization, and enhance productivity.
• Scalability: Ensuring processes can adapt to increased production demands without significant cost increases.
• Data-Driven Decisions: Using analytics to identify bottlenecks, predict outcomes, and allocate resources effectively.

Unlock the secrets to smarter, leaner bioprocessing with sessions that dive into cutting-edge strategies for reducing costs while boosting efficiency. Gain actionable insights to scale seamlessly, minimize waste, and stay ahead in a competitive market. Discover how to achieve more with less - without compromising on quality or compliance.

Risk mitigation is not just a defensive strategy; it is a proactive approach to maintaining excellence in bioprocessing. Ensure operations are robust, compliant, and capable of delivering life-saving therapies at scale.

• Process Predictability: Using risk assessments and modelling to minimize variability and maintain consistent performance.
• Regulatory Compliance: It involves aligning processes with current regulatory standards and preparing for future changes, reducing the risk of non-compliance.
• Patient Safety: By addressing potential risks early, it ensures that therapies meet the highest safety and quality standards, protecting patient health.

Learn to use advanced analytics and AI alongside regulatory-compliance and operational-stability guidance to boost predictability and sustain excellence. Learn to reduce variability, scale confidently, and build resilient systems that deliver high-quality therapies efficiently and reliably.

• Streamlining Cell Line Development for FIH: Accelerate development from pools to GMP supply while meeting regulatory and quality standards.
• Advancing Clone Selection and Predictability: Implement high-throughput screening and stability testing to predict commercial-scale performance reliably.
• Cutting-Edge Integration Technologies: Adopt expression systems, automation, and digital tools to shorten cycle times significantly.

• Optimizing Cell Retention and Harvest Methods: Optimize ATF, TFF, and centrifugation for efficient harvests in high-cell-density perfusion processes.
• Media Customization for High-Titer Success: Tailor media and feeding strategies to support high titers while controlling lactate, ammonia, and osmolality.
• Stress Management and Quality Control: Identify early stress indicators and design upstream processes to reduce metabolic stress, enhancing QbD outcomes.

• Revolutionize Biologics Purification with Cutting-Edge Technologies: Adopt membrane chromatography to increase efficiency, scalability, and cost-effectiveness for large-molecule purification.
• Streamline Downstream Antibody Capture with Precipitation Innovations: Use precipitation plus filtration and membranes to replace Protein A cost-effectively at high mAb titers.
• Transform Downstream Productivity with Real-Time Monitoring and Filtration: Implement PAT for real-time control, reduced variability, and precise large-scale downstream processing.

• Streamlining Digital Biomanufacturing for GMP: Transition disconnected data and manual workflows into validated, scalable, GMP-compliant digital operations with measurable ROI.
• Advancing Predictive Control and Real-Time Manufacturing: Embed analytics and PAT into operations, prioritize decision-critical data, and enable proactive manufacturing control.
• End-to-End Data Integration for Seamless Manufacturing: Replace document handoffs with digital threads to prevent late-stage failures and ensure seamless manufacturing.

• Unlocking Manufacturability for Complex Proteins: Predict risks early, optimize upstream/downstream processes, and implement assay panels for manufacturability.
• CMC Considerations for New Manufacturing Approaches: Align innovative manufacturing with regulatory expectations while integrating analytics to ensure quality and efficiency.
• Transforming CMC with Advanced Analytics: Use data-driven tools to predict risks, optimize decisions, and control aggregation, stability, heterogeneity.

Practical workshops accelerating bioprocess development, analytics, continuous processing and CMC.

• Workshop 1: CMC Roadmap
• Workshop 2: Intensified & Continuous Processing
• Workshop 3: AI and ML Applicability in Bioprocessing
• Workshop 4: BPI School