Conference Day One
Wednesday March 27, 2024

7:30 am Conference Registration & Networking

8:30 am Chair’s Opening Remarks

Control Strategies for a Harmonized Approach to Continuous Processing Adoption

8:45 am Exploring Control Strategies for Enhanced Process Regulation in Continuous Manufacturing

  • Sayantan Chattoraj Team Director - Process Engineering & Analytics, Drug Product Development, GSK

Synopsis

  • Examining different control strategies used in continuous manufacturing
  • Discussing the benefits associated with different control strategies
  • Exploring the role of automation, sensors, and advanced data analytics in enhancing control strategies for continuous manufacturing

9:15 am Closing the Gap in Continuous Manufacturing From Feedback Control to Real-Time Process Monitoring for Achieving Efficient & Reliable Production

Synopsis

  • Understanding the current gap in continuous manufacturing and the need for transitioning from traditional feedback control to real-time process monitoring
  • Evaluating the integration of real-time process monitoring data with feedback control systems to enable timely decision-making and process adjustments
  • Evaluating of the impact of real-time process monitoring on process variability, reducing waste, and increasing product consistency

9:45 am The Integrated Continuous Manufacturing of Small Molecule Pharmaceuticals

  • Stephen Born Senior Director & Head Of Scientific Affairs, CONTINUUS Pharmaceuticals

Synopsis

  • CONTINUUS Pharmaceuticals is dedicated to developing and implementing the fully integrated continuous manufacturing of small molecule pharmaceuticals, from the feeding of raw materials to produce the API, through to producing the drug product final form.
  • An overview of our demonstrated capabilities at the pilot plant level will be presented, as well as our current design for a cGMP facility.

10:15 am Morning Refreshments & Speed Networking

Advancing API & Upstream Process Development to Accelerate Pipeline Progression

11:15 am Exploring How Continuous Flow Chemistry Can Revolutionize Small Molecule Synthesis

Synopsis

  • Analyzing the methodology of continuous flow specifically focusing on drug substance and API
  • Discussing the benefits of continuous flow chemistry, such as enhanced reaction control, improved safety, and scalability
  • Addressing the challenges and considerations in adopting continuous flow chemistry, including equipment selection, optimization, and integration into existing processes

11:45 am Continuous Manufacturing of an AAV-based Gene Therapy

  • Richard Braatz Associate Director & Professor - Faculty, Biomedical Innovation, MIT

Synopsis

• Sharing perfusion process for continuous production of rAAV at high cell density

• Experimentally demonstrated for transient transfection in HEK293 cells

• Presenting good agreement between mechanistic modeling and experimental results

• Demonstrating continuous operations at higher cell densities to increase vector genome titer

12:15 pm Lunch & Networking

1:15 pm Accelerating Continuous Manufacturing Development for Drug Substance With Modular Equipment

Synopsis

  • Discussing the challenges for adopting and commercializing continuous manufacturing at accelerated timelines
  • Discussing design considerations for modular equipment for drug substance manufacturing
  • Exploring the paradigm shift from process-centric development to equipment-centric development to enable CM commercialization

1:45 pm Developing a Groundbreaking Continuous mRNA Production Line Through the Integration of Advanced Process Analytical Technologies and Computational Modeling

Synopsis

• Utilization of PAT and data science in continuous manufacturing of mRNA

• Advanced technologies and computational modelling in continuous production of mRNA

• Determination of mRNA concentration in real-time

2:15 pm Afternoon Networking Break

Improving COGs through Yield Optimization & Waste Minimization

3:00 pm Leveraging Continuous Crystallization for Robust Purity Control & Yield of a Drug Substance Intermediate

Synopsis

  • Exploring the core principles and methodologies of direct continuous antisolvent crystallization applied to isolate a drug substance intermediate
  • Discussing the use of continuous crystallization for robust purity control and consistent isolation via fast filtration
  • Highlighting the integration of continuous reaction, crystallization and isolation to optimize yield, minimize waste, and improve resource utilization

3:30 pm Reducing API development time with Continuous Rapid API Development Systems & Modular Type Packages (MTP)

Synopsis

  • One of the major bottle necks in API development is the time and resource required to carry out multiple experiments as part of an extensive Design of Experiments.
  • A Case Study will be presented describing how AWL’s Rapid API Development platform can carry out fully automated crystallisation, filtration, washing, drying, solids discharge and collection into bottles, significantly reducing experimental lab time.
  • AWL will demonstrate how Modular Type Packages (MTP) can be used to allow for flexible and configurable connections of unit operation modules, and how this can deliver multi-modular systems for both development and production.

4:00 pm Panel Discussion: The New Hype Curve: What is the Future of Continuous Manufacturing Application?

  • Irina Ramos Director - Bioprocess Technology & Engineering, AstraZeneca
  • Manuel Carrondo VP, IBET - Instituto de Biologia Experimental e Tecnologica

Synopsis

Join our expert speakers from today to critically access CM’s maturity within the pharmaceutical landscape and where holds the biggest potential for application and return on investment. 

4:30 pm Chair’s Closing Remarks

4:45 pm End of Conference Day One