Pre-Conference Focus Day

MARCH 23, 2021
10.00 - 17.00 EST I 7.00 - 14.00 PST

Implementing Continuous From Facility Design to Regulatory Filling

9:45 am Chair’s Welcome

10:00 am Facility Design for Continuous Manufacturing Laboratories and Clinical Supply Facilities

Synopsis

• Development of user requirements for an AbbVie continuous manufacturing clinical supply facility
and laboratory
• Design considerations for AbbVie’s continuous manufacturing facility/laboratory and equipment
• Challenges in retrofitting an existing facility to support continuous manufacturing

10:30 am Group Discussion: Facility Design for the Implementation of Continuous Processing

Synopsis

Discussion and troubleshooting:
• What are your key facility design questions?
• How can flexibility be best built into the facility infrastructure and equipment?
• What types of continuous manufacturing facilities are available? Challenges in retrofitting or
building new
• GMP cleaning considerations for continuous reactors to allow product changeover
• Solvent handling and room electrical classification
• Facility GMP design requirements for isolation of APIs

11:00 am

Group Networking

11:30 am Presentation and Group Discussion on Capability Building for CM & Scale up

Synopsis

• Establishing AstraZeneca’s development approach through defined platforms
• AstraZeneca’s approach to building continuous capability – people & technical
• Maximising learning from manufacture with a predominantly outsourced model

12:15 pm

Lunch Break

1:00 pm Modeling & Simulations for Continuous Manufacturing Applications

Synopsis

Modelling and Simulation technology holds great promise for reducing costs, improving quality, and shortening the time-to-market for process development and emerging therapeutics. However
these benefits are largely underutilized in industry to improve and advance continuous processes. This workshop will be led by Nima Yazdanpanah and help you reap the cost, quality and regulatory -related benefits to ensure a robust modelling and simulation strategy, tools, and applications.
In this 2 hour session we will explore:
• Modeling and simulation for CM process design, scaleup, integration, and technoeconomic analysis
• Modeling and simulation for CM process control, risk analysis, optimization, control strategy development
• Virtual twin for CM process evaluation, operator training, virtual doe, recipe and CPP optimization

3:00 pm

Afternoon Refreshment Break

3:30 pm Sanofi’s Massachusetts Digital Facility Delivering a Continuous Process

  • Navin Tiwari Head of Digital Shop Floor Automation, Sanofi
  • Armin Opitz Director, MSAT (Manufacturing Science and Technology), Sanofi

Synopsis

  • Overview of Sanofi’s Digital Facility
  • Digital Infrastructure for Continuous Processing
  • Tech Transfer & Operationalizing Continuous Processing

4:15 pm Group Discussion: Revolutionizing Your Regulatory Strategy

Synopsis

Tune your CMC regulatory strategy for Continuous. Through presentations, group discussions, gain insight on the following:
• Gaining regulatory Approval in CM
• Replacing “3 batch validation” in CM to ensure quality
• Defining Industry 4.0 data sets – how much data is required for continuous regulatory validation

5:00 pm

End of Preconference Focus Day