Jan 29 – Jan 31, 2019
Boston, MA

Day One
Wednesday January 30, 2019

Day Two
Thursday January 31, 2019

07:30
Morning Coffee & Registration

08:30
Chair’s Opening Remarks

Commercial Environment for Continuous Manufacturing

08:35
Opening Address: FDA’s CBER’s Advanced Manufacturing Initiative

Synopsis

  • Enhancing innovations in emerging technology for advanced manufacturing
  • How does CBER review and evaluate novel technologies, particularly for complex biologics?
  • The support from CBER – industry engagement and funding opportunities

09:30
Case Study: Janssen’s Success Story in Implementing Continuous Manufacturing

Synopsis

  • The journey from switching to project implementation and tech transfer
  • Lessons learned and looking beyond: what’s next for API continuous manufacturing?

09:40
Panel Discussion: Tailoring your Technology and Business Strategy for Success

Synopsis

  • How to establish an investment roadmap?
  • Implementing an effective strategy to drive technology investment
  • Creating a culture of innovation in manufacturing

Audience will also have a chance to ask panellists their burning questions at the end of this session.

10:30
Speed Networking & Morning Coffee

12.00 Development, Tech Transfer, and Implementation of a Flow Process for Production of an API

A synthetic route was selected and developed specifically for use in flow
• A new facility dedicated to flow chemistry was built and the process was transferred
• Four synthetic steps were run simultaneously to produce API
Luke Webster, Associate Consultant Engineer, Eli Lilly & Company

12.30 Latest Research on Applications of Continuous Processing in Drug Products

• What’s electrospinning and future of this application in continuous manufacturing?
• Removal of multi-steps from APIs to finished dosage forms
• Potential to scale up to commercial use
• 3D printing model to demonstrate feasibility
Blair Brettmann , Assistant Professor, Georgia Institute of Technology

12.00 Integrated Continuous Biomanufacturing (ICB) Adaptation to Complex Modalities

Recent success in commercialization of enzyme with an ICB v1 process
• Benefits to footprint decrease, rapid integrated purification and continuous perfusion operations
• Expansion of Sanofi’s ICB platform – business case consideration, including complex modalities where in-process kinetics can impact on product quality outcome
• Suitability of adaptation for complex modalities
Marcus Fiadeiro, Associate Director, DSP, Continuous Manufacturing Skill Center, Sanofi

12.30 Integrated Continuous Bioprocessing Platform Development – New Data, Partnership strategies, Integration, and PAT

Steady-state CCTC data from multiple modalities
• PAT and manufacturing – overcoming challenges with effective partnerships
• Integration of multiple unit operations – challenges and successes and the path forward
Oleg Shinkazh, President & CEO, Chromatan

13:00
Networking Lunch

14.00 PAT & Real-Time Product Release

Latest advancements of PATs
• When should you do product release? Is real time a reality?
• Product control to ensure quality medicines
Douglas B. Hausner, Associate Director, Rutgers University/C-SOPS

15.00 Roundtable Discussion:

This session is hosted by Asymchem, Inc. and will split the audience into mini-groups for
more in-depth discussion based on this morning’s sessions,
focusing on:
• Does CM offer more flexibility on equipment requirements?
• Assessing CM for legacy products and new candidates – how to choose?
• What data and validation should we consider during filing?
We will re-group at the end of the session for learning sharing.
Led by Miguel Angel Gonzalez, Senior Director, Chemical Engineering, Asymchem Inc.

14.00 Impurity in Continuous Processing

• The complexity of impurity and crystallization during continuous processing
• Progress in using PAT to drive purification during C
Satish Sharma, Scientist II, Bristol-Myers Squibb

14.30 Process Concepts from Start to Finish with Brilliant Potential

Process Concepts from Start to Finish with Brilliant Potential

  • Balancing the potential & benefits of connected and continuous manufacturing
  • Challenges like the need for specialized process understanding and shifts in current resource models for development and operations leading to slow adoption
  • How GE Healthcare Life Sciences builds confidence in technology and process knowledge, addresses regulatory expectations, and most importantly, supports a convincing business case for connected and CP in biomanufacturing

Avril Vermunt, Continuous Program Manager, GE Healthcare Life Sciences

14.40 Different Continuous Chromatography Systems for Continuous Capture

• Different continuous chromatography technologies are currently available in the market, which differ in configuration, control elements
• Each technology comes with different benefits and limitations, selection of one can be based on requirements and feasibility
• Comparison of different systems will be presented with feasibility data and operational aspects
Sujit Jain, Group Leader, Downstream Process Development, Shire

15.10 Roundtable Discussion:

How Much Can You Yield? Translating Food Industry’s Technology to Biologics CM

  • Who are we? Purolite’s platform and services
  • Overcoming the concern of yield and impurity – uniform particles in chromatography columns to achieve a higher yield and pure product in downstream processing
  • Translating experience in food industry into biologics: quality assurance and next steps
Fred Ghanem, North American Business Manager, Purolite Life Sciences

15:30
Afternoon Tea & Networking

16:00
Spotlight Talk Sponsored by LEWA-YMC: Scale-Up & Validation Aspects of Continuous Twin-Column Chromatography for mAb Capture

Synopsis

  • Demonstrating data and confidence of scale-up of twin-column chromatography
    for mAb capture
  • The importance of validation and control design

16:30
Leverage Continuous Manufacturing to Reduce Facility Footprint

  • Neil Soice Director, Drug Substance Technologies, Amgen

Synopsis

  • Development of integrated continuous operations
  • Explore the benefits and constraints of continuous processing
  • Evaluate the impacts of the application of disposables to enable the design and construction of facilities
  • What does it mean to capital investment and build time?

17:15
Chair’s Closing Comments of Day 1

17:20
Poster Session

Synopsis

The poster session will welcome industry colleagues and academics to reveal their latest projects.

If you have a scientific breakthrough or research paper you’d like to showcase with the CCP community, please kindly drop us a line.

 

18:30
End of Day 1