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

  • Nidhi Kotecha Program Director, Gates Biomanufacturing Facility

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

  • Elliott Schmitt Manufacturing Intelligence, PAT, Novo Nordisk Engineering

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

  • Aishwarya Ramanan Downstream Manufacturing, Science, Technologies Labs & Innovation Scientist PAT, Seagen

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

  • Rohit Lokhande Senior Continuous Manufacturing Manager, U.S. Pharmacopeia

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

  • Fabrice Thomas Senior R&D Manager - PAT Raman Technology, MilliporeSigma

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

4:45 pm Chair’s Closing Remarks