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

  • Sankaran Anantharaman Head of PAT & Innovation Labs - Small Molecule CMC – Biologics, Abbvie
  • Mark Henson Senior Scientific Fellow, Technology Lifecycle Implementation, Takeda Pharmaceutical

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

LumaCyte

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

  • Nili Persits Founder, Massachusetts Institute of Technology

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

  • 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

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

  • 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

Enhancing PAT Implementation in Synthetic Molecule Manufacturing

2:45 pm Optimizing Flow Chemistry With Advanced PAT Tools for Enhanced Efficiency and Reliability

  • Darren Whitaker Automation & Control in Process Chemistry Development, Takeda Pharmaceutical

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

millaporesigma

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

5:45 pm Chair’s Closing Remarks