Conference Day One
7.45 am – 9.45 am Workshop A Optimizing Automation & Human Intervention in Continuous Processing
7.45 am Check in Morning Coffee & Light Breakfast
Optimizing Automation and Human Intervention in Continuous Processing
9:55 am Chair’s Opening Remarks
Maximizing Efficiency & Compliance in PAT Lifecycle Management
10:00 am Crossing the Finishing Line: Implementation of RTRT/PAT for a BioTech Drug Product
Synopsis
- The elements of an RTRT/PAT-based control strategy for a BioTech Drug Product
- Ensuring effective commercial adoption and overcoming technical, regulatory and compliance-related challenges for an aseptic process
- Harmonizing the goals of development and technical operation to ensure a smooth and sustainable implementation. What are the lessons learned?
10:30 am Fireside Chat: Optimizing PAT Transition from Early Development to Clinical Phases
Synopsis
- Utilizing PAT tools in the development phase to optimize processes and improve process understanding, paving the way for effective clinical GMP (Good Manufacturing Practice) implementation
- Addressing and mitigating process developers’ reluctance to monitor processes during manufacturing, ensuring the timely and efficient deployment of PAT tools
- Implementing strategies to expedite the transition from development to clinical phases, minimizing delays and enhancing overall project timelines
11:15 am Session Reserved for Lumacyte
Synopsis
11:45 am Morning Break & Speed Networking
Streamlining Biologics Manufacturing for Efficiency
12:45 pm Scaling Biologic Manufacturing: Bridging the Gap Between Bench Success and GMP Readiness
Synopsis
- Addressing the challenges of scaling technologies from small-scale to large-scale processes in biologic production
- Simplifying technology integration: Ensuring new systems are user-friendly and require minimal retraining for existing teams
- Best practices for preparing the workforce and infrastructure to adopt advanced manufacturing technologies without significant disruption
1:15 pm Managing Complexity in Gene Therapy Manufacturing
Synopsis
- Managing the complexity of gene therapy production by maintaining precise control over multiple variables
- Using sophisticated PAT tools to monitor and control transduction efficiency and vector potency
- Implementing detailed monitoring to ensure the stability and efficacy of the final gene therapy product
Enhancing PAT Implementation in Synthetic Molecule Manufacturing
12:45 pm Navigating the Emerging Landscape of Oligonucleotide PAT: Challenges & Strategies
Synopsis
- Explore the current challenges in developing PAT for oligonucleotides, including the lack of standardized processes and the complexities compared to well-established small molecule oral solid dosage forms
- Discuss potential strategies and approaches to align processing steps and optimizing PAT integration, drawing on early experiences and lessons learned from existing implementations
- Highlight the importance of collaboration and knowledge sharing within the industry to advance oligonucleotide PAT, and propose ways to standardize and innovate in this evolving field
1:15 pm Technology Selection and Implementation
Synopsis
- Selecting and implementing appropriate PAT tools tailored to each unique API process, considering suitable sensors and analyzers
- Carefully considering process requirements to ensure effective implementation of PAT tools
- Choosing between NIR and Raman spectroscopy for monitoring specific chemical reactions to optimize the manufacturing process
1:45 pm Lunch & Networking
Integrating Advanced Analytics in Biologics & Manufacturing: Challenges & Solutions
2:45 pm Integrating Advanced Analytics in Biologics & Manufacturing: Challenges & Solutions
Synopsis
- Examining how PAT tools are integrated into downstream purification processes for biologics
- Addressing the challenges encountered when integrating advanced analytical technologies into downstream processes
- Discussing strategies implemented to overcome these hurdles, including training staff and modifying process controls
3:15 pm Integrating Advanced Technologies in Manufacturing for Supply Chain Excellence
Synopsis
- Implementing AI and PAT in manufacturing processes to optimize production, reduce waste and ensure product consistency
- Overcoming challenges in global material sourcing by employing innovative logistics solutions and strategic partnerships
- Enhancing supply chain resilience by adopting real-time data analytics and predictive modeling to anticipate and address potential disruptions
Enhancing PAT Implementation in Synthetic Molecule Manufacturing
2:45 pm Optimizing Flow Chemistry With Advanced PAT Tools for Enhanced Efficiency and Reliability
Synopsis
- Implementing advanced PAT tools for real-time monitoring in flow chemistry, enabling continuous data collection and process optimization
- Developing systems for automated feedback and control in flow chemistry to reduce human intervention and increase process reliability
- Utilizing advanced data analytics and machine learning to interpret complex flow chemistry data in real-time, enhancing decision-making and process adjustments
3:15 pm Roundtable Discussion: Enhancing Data Management and Analysis in Oligonucleotide Manufacturing
Synopsis
- Developing strategies for simultaneous monitoring of CQAs and CPPs in oligonucleotide manufacturing to enhance process control and product quality
- Utilizing advanced data analytics and machine learning techniques to handle and analyze large volumes of data
- from PAT tools, providing actionable insights and improving decision-making
- Incorporating PAT tools into existing manufacturing systems and infrastructure, ensuring compatibility and efficiency through significant investment and technical expertise
3:45 pm Afternoon break
4:15 pm Session reserved for MilliporeSigma
Synopsis
Harnessing Advanced Analytical Technologies for Optimized PAT
4:45 pm Optimizing Liquid Chromatography for Superior Process Efficiency and Control
Synopsis
- Implementing liquid chromatography systems to improve precision and reduce solvent usage, enhancing sustainability and operational efficiency
- Facilitating real-time data collection and immediate process adjustments through on-thespot analysis with portable liquid chromatography systems
- Integrating liquid chromatography with continuous flow systems to ensure seamless monitoring and control throughout the production process
5:15 pm Advancing Real-Time Reaction Monitoring With NMR Technology
Synopsis
- Utilizing bench-top NMR (Nuclear Magnetic Resonance) for real-time chemical reaction monitoring, providing detailed insights into reaction dynamics
- Addressing the resolution limitations of bench-top NMR systems by focusing on reactions with distinctive signals, ensuring accurate and actionable data
- Developing strategies to effectively integrate NMR into continuous flow processes, enabling uninterrupted monitoring and timely interventions