ISCMP 2018 Reflection on the Business Case of the first Batch to Continuous Manufacturing converted product approved by the FDA Mauricio Futran, VP Advanced Technology COE Janssen London, 3 October 2018
Donna Williams, Cheerful Donna Williams, and autistic artist, author and renowned autism advocate, was diagnosed with breast cancer in 2011.
Continuous Manufacturing, and why we engaged
Assure available affordable medicines of highest quality
© 2018 Janssen Supply Group, LLC, and/or its affiliates. All rights reserved. Any use of this material without specific permission of Janssen is strictly prohibited.
Continuous Manufacturing, and why we engaged
Assure available affordable medicines of highest quality
Sustainable processes, minimal waste
© 2018 Janssen Supply Group, LLC, and/or its affiliates. All rights reserved. Any use of this material without specific permission of Janssen is strictly prohibited.
Continuous Manufacturing, and why we engaged
Assure available affordable medicines of highest quality
Sustainable processes, minimal waste
Safe Processes
© 2018 Janssen Supply Group, LLC, and/or its affiliates. All rights reserved. Any use of this material without specific permission of Janssen is strictly prohibited.
Continuous Manufacturing, and why we engaged
Assure available affordable medicines of highest quality
Sustainable processes, minimal waste
Safe Processes
Reputation for superior quality; Produce in a cost efficient way
© 2018 Janssen Supply Group, LLC, and/or its affiliates. All rights reserved. Any use of this material without specific permission of Janssen is strictly prohibited.
General Benefits & Challenges of Continuous Manufacturing Patients: Road to perfection (ok, 6 sigma): Understand, design, Measure, control Speed to market Supply chain agility and flexibility
© 2018 Janssen Supply Group, LLC, and/or its affiliates. All rights reserved. Any use of this material without specific permission of Janssen is strictly prohibited.
General Benefits & Challenges of Continuous Manufacturing Patients: Road to perfection (ok, 6 sigma): Understand, design, Measure, control Speed to market Supply chain agility and flexibility Employees: Safer design – exposure, explosion, exothermic reactions (DS)
© 2018 Janssen Supply Group, LLC, and/or its affiliates. All rights reserved. Any use of this material without specific permission of Janssen is strictly prohibited.
General Benefits & Challenges of Continuous Manufacturing Patients: Road to perfection (ok, 6 sigma): Understand, design, Measure, control Speed to market Supply chain agility and flexibility Employees: Safer design – exposure, explosion, exothermic reactions (DS) Community: Smaller footprint, Less energy and water consumption Less waste
© 2018 Janssen Supply Group, LLC, and/or its affiliates. All rights reserved. Any use of this material without specific permission of Janssen is strictly prohibited.
General Benefits & Challenges of Continuous Manufacturing Patients: Road to perfection (ok, 6 sigma): Understand, design, Measure, control Speed to market Supply chain agility and flexibility Employees: Safer design – exposure, explosion, exothermic reactions (DS) Community: Smaller footprint, Less energy and water consumption, Less waste Shareholders: Superior quality through process understanding, measurement and control Enabling Real Time Release shortening release time and reducing lab effort Development: More, faster and better experiments with less API Transfer: Similar equipment development to manufacturing – include modeling Manufacturing: Better yield, no WIP, reduced production effort, shorter cycle times © 2018 Janssen Supply Group, LLC, and/or its affiliates. All rights reserved. Any use of this material without specific permission of Janssen is strictly prohibited.
Janssen Deployment strategy Strategy • Load existing lines with legacy products • Move legacy products back to batch if needed • Build commercial line to mirror development line • Use CM as preferred OSD development platform • First DC, then RC, then WG Equipent design • Several different lines easy transfer • Volatile pipeline need for flexibility • Robust eqt. less start/stop, max. efficiency Aspirations • Better yields and Change Over times • Flexible throughput 15-100kg • Flexible & modular design (hardware, software and PAT) © 2018 Janssen Supply Group, LLC, and/or its affiliates. All rights reserved. Any use of this material without specific permission of Janssen is strictly prohibited.
Business case learnings (Equipment) Proven Virtues: Significant Cycle Time reduction Integration software Impact of materials
© 2018 Janssen Supply Group, LLC, and/or its affiliates. All rights reserved. Any use of this material without specific permission of Janssen is strictly prohibited.
Cleanability Change-over time
Business case learnings (Process) Process Design learnings: Selection of correct tracer for RTD modeling Seggregation risk during transport of granulated material BU for multiple API’s, low dose formulations Variation of torque (wet granulation) over time
Proven Virtues: Very Consistant process High process resolution (good visibility of trends) © 2018 Janssen Supply Group, LLC, and/or its affiliates. All rights reserved. Any use of this material without specific permission of Janssen is strictly prohibited.
Business case learnings (Cost) Cost effectiveness learnings: TT benefits depend on similarity – models will help Initially more effort needed for development Yield critical for many business cases Manufacturing benefits need time Prepare for pipeline volatility
© 2018 Janssen Supply Group, LLC, and/or its affiliates. All rights reserved. Any use of this material without specific permission of Janssen is strictly prohibited.
How we connect and collaborate, and why it matters How can Pharma Companies help each other? Share/build understanding of Control Strategies, Equipment, Risks and impact of variation in material, process & environment Create trust based on data and real case studies Align on concepts for equipment harmonization How Does Janssen collaborate? Participating in or leading Industry Consortia Start collaborations in fields where they are missing What do we want to achieve? Increase understanding, Shared models, RTR and BRR by exception Interchangeable unit operations, Fast and easy Clean Out, good yield © 2018 Janssen Supply Group, LLC, and/or its affiliates. All rights reserved. Any use of this material without specific permission of Janssen is strictly prohibited.
The Future – we shape it!
Lawrence Yu, ISPE 2018 CM workshop
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Material Characterization database
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ISPE COP to streamline (modular) design and align on standard interfaces
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Drive collaboration in the industry Strong connection with other Innovators, Multiple Academic collaborations
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Support all guidance documents Many interactions with health authorities Global filing of Prezista to facilitate interactions
© 2018 Janssen Supply Group, LLC, and/or its affiliates. All rights reserved. Any use of this material without specific permission of Janssen is strictly prohibited.