Conference Day Two
Thursday March 28, 2024

8:45 am Chair’s Opening Remarks

Downstream Innovation for Perfectly Pure Products & Medicines

9:00 am Bioburden Control Strategies for Continuous Downstream Processing

  • Irina Ramos Director of Bioprocess Technologies and Engineering, AstraZeneca

Synopsis

With product quality and regulatory compliance, demonstrating robust bioburden control strategies for downstream continuous manufacturing is admittedly one of the most challenging tasks. In this session, the speaker will share implementation and validation techniques to help you achieve GMP compliance, confidence in product quality and real time release.

9:30 am Revolutionizing Drug Product Transformation by Unleashing the Potential of Continuous Spray Drying Through Scientific Approaches

Synopsis

  • Exploring the significance and challenges associated with transforming drug products into desired forms for enhanced efficacy and delivery
  • Delving into the molecular-level understanding of how continuous spray drying influences drug product characteristics
  • Addressing formulation challenges associated with spray drying, such as powder morphology and discussing scientific approaches to overcome these challenges

10:00 am Advancing Purification of New Modalities With Continuous Chromatography

  • Manuel Carrondo Vice President - Business Strategy, IBET - Instituto de Biologia Experimental e Tecnologica

Synopsis

  • Discussing how higher titers are obtained
  • Addressing better quality of product is a normal outcome
  • Showing application for both gene and cell therapies (GCT) and also exosomes
  • Demonstrating substantial economic improvements in the purification process
  • Exploring that integrated continuous full process is possible for GCT

10:30 am Session Reserved for EcoLab

  • Fred Ohsiek Senior Manager - Validation Life Sciences, Ecolab Ltd

Synopsis

  • CIP Cleaning Sustainability
  • Elements of an optimized cleaning process
  • How to efficiently optimize a CIP cleaning process
  • Hidden benefits of optimizing legacy cleaning processes 

11:00 am Morning Refreshment & Networking

Advancing Automation & Process Monitoring in Regulated Environments

11:30 am Spotlighting Process Modelling & Simulation in Continuous Manufacturing of Small Molecule APIs To Bridge Theory & Practice Together

  • Robert Yule Head Of Process Operations, Data & Modelling, Sanofi

Synopsis

  • Analyzing the concept of process modelling and simulation as a valuable tool to bridge the gap between theoretical understanding and practical implementation in continuous manufacturing.
  • Discussing how process modelling enables virtual experimentation, process understanding, and prediction of performance
  • Exploring various modelling approaches used in continuous manufacturing, such as mathematical models, computational fluid dynamics (CFD), and discrete event simulation

12:00 pm Leveraging PAT for Real-Time Quality Assurance in Continuous Manufacturing to Maximize Quality & Efficiency

Synopsis

  • Discussing the importance of inline process monitoring and real-time data acquisition in ensuring product quality and regulatory compliance 
  • Exploring strategies for identifying and addressing process issues in real time, including the ability to divert and correct deviations as they occur 
  • Highlighting the role of PAT in segmenting the continuous manufacturing process to enable targeted quality control and assurance

12:30 pm Lunch & Networking

1:30 pm Technological Breakthroughs for Process Modelling, Real-time Monitoring & Control in Small Molecule Drug Product Manufacturing

  • Ravendra Singh Professor Department of Chemical and Biochemical Engineering, Rutgers University

Synopsis

  • Discussing the integration of digital twins
  • Exploring the technological innovations that enable real-time quality assurance during small molecule drug product manufacturing
  • Exploring design and implementation of advanced control system to ensure product quality

Streamlined Tech Transfer for Smooth Scale Up

2:00 pm Harnessing Machine Learning for Automated Visual Inspection To streamline in Tech Transfer

Synopsis

  • How supervised and unsupervised learning can be applied to image recognition with benefits at different stages of the development process
  • Exploring how automated vision inspection reduces the need for manual operation while standardizing the assessment.

2:30 pm Development of a Scalable Multi-stage Flow Reaction for the Synthesis of Ligands

Synopsis

  • Discussing the optimization of a complex flow reaction from small scale to multi-kilogram scale and the intricacies involved in using different flow configurations (i.e., plug flow reactor vs. continuous stirred tank reactor)
  • Analyzing the various stages of flow process development, the problems encountered, and the solutions used to enable the process to continue
  • Exploring lithiation chemistry in flow, the common issues that arise, and the approaches employed to counteract these issues

3:30 pm Chair’s Closing Remarks

3:45 pm End of Summit