Conference Day One
8.15 am Check in Morning Coffee & Light Breakfast
8:55 am Chair’s Opening Remarks
9:00 am Quantitative Cellular PAT Analytics Driving Improvements in Advanced Therapy Process and Production Outcomes
Synopsis
- Label-free analysis of intrinsic biochemical and biophysical properties of cells provides real-time insights into cellular changes occurring throughout a manufacturing process. Additionally, ensuring robust cellular fitness of starting material is a crucial component to manufacturing and treatment success
- Learn how Laser Force Cytology™, a label-free, quantitative precision PAT enables real-time monitoring of CQAs and CPPs delivers insights into complex manufacturing processes through its optical force univariate and multivariate machine learning predictive capabilities
9:30 am Panel Discussion: 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
10.15 am Morning Break & Speed Networking
11:15 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?
11:45 am Navigating Regulatory & Compliance Challenges in PAT Implementation
Synopsis
- Establish secure, reliable data practices that comply with regulatory standards for trustworthy, auditable records in PAT
- Develop robust data handling for machine learning inputs, ensuring quality and accuracy to support real-time decision-making
- Employ advanced PAT tools for compliance monitoring and error reduction, ensuring adherence to GMP standards for smoother commercial adoption
12:15 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
12.45 pm Lunch & Speed Networking
1:45 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
2:15 pm Integrating Advanced Analytical Technologies for Biologics into Downstream Processes
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
2:45 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
3.15 pm Afternoon Break
3:45 pm Holistic Approach to Optimize PAT Tools Implementation in the Lab & Facility of the Future
Synopsis
- Streamlining the implementation of Raman technology with ready-to-use capabilities, straylight management and connectivity compliance
- Highlighting capabilities of in-line, on-line and at-line Raman sensors for CQA and CPP monitoring in USP, DSP and new modality areas, from process development to product release in manufacturing
- Proposing various strategies and assessing performances of PAT combination and their coupling with digital tools
4:15 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