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7:30 am Registration & Welcome Coffee

8:15 am Chair’s Opening Remarks

8:30 am Opening Address: The New Launch: CBER’s Advanced Manufacturing for Complex Biologics Products

  • Manuel Osorio Senior Scientist & Program Lead for Emerging Technologies, FDA/CBER

9:00 am Continuous Manufacturing as a Default Platform for Oral Solid Drug Products

9:30 am The Possibility of End-to-End Implementation of Continuous Manufacturing – From Development to Supply

  • Justin Moser Director – Advanced Manufacturing Technology, Merck & Co., Inc.

10:00 am Panel Discussion: Is Continuous Manufacturing for Legacy Product Only? Can we be Courageous and Use it for NDA?

10:45 am Speed Networking & Morning Coffee

Small Molecules Stream

Biologics Stream

11.45 am Development and Implementation of a Commercial GMP Flow Process to Manufacture a Carbapenem Intermediate

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Miguel Gonzalez, Senior Director, Chemical Engineering, Asymchem

12.15 pm Implementation of Continuous Pharmaceutical Technology Through Open Innovation in the UK Catapult Network

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Dave Berry, Manager of Complex Particles, CPI UK

11.45 am Towards Continuous Drying Technologies for Parenterals

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Sune Klint Anderson, Principal Scientist, Janssen R&D

12.15 pm A Continuous and Controlled Pharmaceutical Freeze-Drying Technology for Unit Doses

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Jos Cover, Academic Researcher, University of Ghent

12:45 pm Networking Lunch

13.45 pm Real Time Product Release – What’s the Strategy and Best Practice?

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Douglas Hausner, Associate Director, Rutgers University & C-SOPS

14.15 pm Commercializing New Chemical Technologies in Flow

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Kaid Harper, Senior Scientist, AbbVie

 

 

 

 

 

14.45 pm CDC-50: A Case Study on 120-Hour of Continuous Direct Compression to Drive Process Flexibility, Yield, Recovery & Overall Equipment Efficiency

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Richard Steiner, Business Development Manager, Continuous Technologies, GEA

13.45 pm Design of Jetted Protein A Resins for Continuous Chromatography

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Hans Johansson, Global Applications Director, Life Sciences, Purolite

14.05 pm Digital Focus on Continuous Bioprocessing

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Georgie Gjoka, Engineer, Continuous Manufacturing Skill Center, Sanofi Genzyme

14.35 pm synTQ – PAT in Continuous and Batch Manufacturing for Biotechs

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Paul Gillham, Technical Sales Manager, synTQ by Optimal Industrial Technologies Limited

14.45 pm Multi-Column Chromatography Going Mainstream

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Gerard Gach, Chief Marketing Officer, YMC Process Technologies

3:00 pm Afternoon Networking Tea & Poster Session

3:45 pm Creating a Common Language and Framework to Support Continuous Manufacturing Globally

  • Ganapathy Mohan Executive Director, Head of External Affairs (Quality), Merck & Co., Inc.

4:15 pm Continuous Downstream Processing – Where Are We in Regard of Comparability and Regulatory Challenges?

  • Klaus Kaiser Head Downstream Development, Product Supply, Pharmaceuticals, Bayer AG

4:45 pm Roundtable

  • Lynne Frick Co-Executive Director, Founder, BioInnovation Group, Inc., BioGuides LLC
  • Thomas Erdenberger Process Development Consultant, Sartorius Stedim Biotech

5:30 pm Chair’s Closing Remarks & End of Day 1

5:35 pm Poster Session