8:30 am Breakfast Interactive Deep Dive: Scale up Trouble Shooting & Digital Solutions

  • Jin-Ping Lim Program Director Advanced Manufacturing , SRI Biosciences, SRI International

10:30 am Chairs Opening Remarks

Optimization of Reactions in Flow to Enhance Yield

10:40 am Flow Chemistry as an Enabling Technology to Advance Programs: AMG 397

Synopsis

• High-volume continuous photochemistry enabled the team to overcome supply chain challenges
• A precise continuous methylation ensured consistent DS quality under GMP conditions
• Rapid scale-up from bench-scale to commercial Scale under GMP

11:10 am Application of Continuous Flow Aminolysis in Process Development

Synopsis

• Flow enabling construction of C-N bonds
• Use of volatile amines under high T/P
• Demonstrated benefits of worker safety, cost savings and cycle time reduction

11:40 am Virtual Speed Networking

Synopsis

Get matched with a fellow attendee or speaker for an introductory chat – click to exchange virtual business cards and expand your flow chemistry network

Conquering Control: Real Time Monitoring & cGMP Compliance

12:10 pm Continuous Processing – How to revolution the manufacturing and supply chain paradigm for the Pharma industry

Synopsis

• In the past decade, there has been a growing interest in the application of continuous processing in the pharmaceutical industry with 100s millions of investments at several of our competitors and several products delivered to the market using this technology.
• Continuous processing demonstrates several value propositions for the Pharmaceutical industry.
• Amongst them we can name, access to better chemistry, product quality enhancement, reduction of CoGs but mostly speed to market where pivotal to launch is drastically accelerated. Continuous processing is a key element of the “play to win” strategy set by Sanofi enabling faster and better access to medicines to our patients

12:40 pm New Paradigms in Automated & Autonomous Process Development Technologies at AbbVie

Synopsis

This talk with describe AbbVie’s efforts in:
• Providing an “end-to-end” integration of automation control and data management (collection, processing, storage, and interpretation) within the R&D labs
• Enhancing R&D laboratory capabilities as a result of “Custom Automation” initiatives
• Ongoing efforts to incorporate data science techniques into R&D experimental design and execution

1:10 pm Round Table: Impact of ICH Q13 on Flow Chemistry for Quality Control

  • Martin Johnson Senior Engineering Advisor, Process Design and Development , Eli Lilly and Company
  • Benjamin Yang Associate Director, Regulatory Affairs , AstraZeneca

Synopsis

• How will these guidelines change current best practice for manufacturing and validation in flow
• Contrasting suitability and application for drug substance vs drug product
• Guidance on PAT frequency and impurities for quality control
• Any foreseeable pain points including run time
• Round table discussions make the most out of the conference platform interactivity. Share your audio and video to get involved in group discussion on hot topics and share your perspective

1:30 pm Networking Lunch

Synopsis

Visit the virtual exhibition hall to explore the solutions are partners have on offer, download whitepapers and view bonus videos

Automation, AI & Digitalization

2:15 pm Panel Discussion: Bridging the Gap Between Chemistry & Engineering

  • Milad Abolhasani Assistant Professor of Chemical & Biomolecular Engineering , North Carolina State University
  • Moiz Diwan Director, Head of Enabling Technology Development Group, AbbVie
  • Andrew Hague Principal Development Scientist , Immunogen
  • Ayman Allian Engineering Advisor, Eli Lilly and Company

Synopsis

• Making the move from ‘equivalents’ thinking to ‘flow’ rate thinking
• Lab scale to development to pilot scale, at what point do chemistry and engineering teams need to be combined?
• What can we learn from each other, and what isn’t being communicated?

3:00 pm Flow Chemistry Meets Machine Learning: Autonomous Flow Reactors for Accelerated Development of Specialty Chemicals

  • Milad Abolhasani Assistant Professor of Chemical & Biomolecular Engineering , North Carolina State University

Synopsis

• Autonomous robotic experimentation
• Robo-fluidic microprocessors
• Reconfigurable modular flow reactors
• Continuous flow manufacturing progress in specialty chemicals

3:30 pm Combining AI and Automation to Accelerate Molecular Discovery

  • Nathan Collins Chief Strategy Officer , SRI BioSciences, SRI International

Synopsis

• AI driven retrosynthetic analysis and route design for flow chemistry
• Use of integrated AI molecular design and flow chemistry automation in the ‘design-make-test’ cycle
• Data drive integration of batch and flow methods for reaction screening and optimization

4:00 pm Afternoon Tea and Networking

Synopsis

Join networking coffee rooms or schedule 1-2-1 meetings on the platform

API Integration with Downstream Processing

4:30 pm API Continuous Cooling & Antisolvent Crystallization for Kinetic Impurity Rejection in cGMP Manufacturing

  • Martin Johnson Senior Engineering Advisor, Process Design and Development , Eli Lilly and Company

Synopsis

• Crystallization of 204 kg final API was accomplished continuously using MSMPRs in cGMP manufacturing
• Continuous crystallization was needed for kinetic rejection of a key quinoline dimer impurity which could not be reliably and consistently rejected thermodynamically using more traditional batch processing methods
• The R&D investigated the impact of temperature, mean residence time, solvent/antisolvent composition, and the number of MSMPRs in series on solids fouling, impurity rejection, supersaturation, crystal form control, crystal morphology, and particle size distribution
• Population balance modeling reduced the number of experiments required to gain process understanding, quickly predicted that the desired particle size distribution was not attainable in the MSMPRs alone without milling, and predicted that time to reach steady state for particle size was about 1 day
• Intermittent flow from the continuous evaporator to the continuous cooling crystallizer eliminated solids bearding on the end of the entry piping into the MSMPR

5:00 pm Crystallization & Isolation in Miniaturized Medicine Manufacturing Machines

  • Naomi Briggs Vice President Research & Development , On Demand Pharmaceuticals

Synopsis

• Developed a general workflow for continuous crystallization process development for cooling and antisolvent methods using MSMPRs
• Demonstrated production of 5 APIs (Ciprofloxacin Hydrochloride, Diazepam, Atropine Sulfate, Diphenhydramine Hydrochloride, Lidocaine Hydrochloride) in 3 weeks • Designed and integrated a semi continuous filtration washing and drying device for isolation of solids
• Continued process development and optimization of ciprofloxacin hydrochloride manufacturing to improve through-put, yield, and physicochemical properties

5:30 pm Closing Remarks

5:45 pm Close of Day 2