Jan 30 – Feb 1, 2018
Boston, MA

Register by Friday, December 15 to save up to $500!

Day One
Wednesday January 31, 2018

Day Two
Thursday February 1, 2018

08.30
Coffee & Registration

09.00
Chair’s Opening Remarks

Continuous Manufacturing Regulatory Updates

09.10
The Need to Define & Standardize Global CM Guidance

  • Ding Ming VP, Research & Innovation, U.S. Pharmacopeia

Synopsis

• Hear USP’s perspective on continuous processing, and a comparison between US, EMEA and APAC
• Learn how to successfully interact and engage with regulatory agencies
• Address the challenges of defining quality standard globally
• What’s next? Assess quality and risk management guidelines

09.40
Roundtable Discussion: Establishing a Winning Business Case for Investment

  • Sanjeev Kothari Senior Director of Pharmaceutical Chemistry and Formulations, Ardelyx, Inc.

Synopsis

• Weighing your options: highly automated batch processing vs. continuous manufacturing
• Discussing upfront investment costs against long-term benefits
• Defining your risk framework and laying out a mitigation strategy
• From feasibility study to evaluation to phase 1 – how do you convince your organization to switch?
• Accelerating time to market with commercial CM

10.20
Speed Networking & Coffee Break

Where Are We? Biologics CM Advancements

11.40
End-to-End Integrated Processing Using Continuous/Batch Hybrid Systems

  • Robert Fahrner Senior Principal Scientist & Group Leader, Bioprocess R&D, Pfizer, Inc.

Synopsis

• Integrating upstream and downstream operations
• Analyzing results from pilot scale operations and options for scaling up
• Exploring pathways to implementation

12.10
Strategy for Continuous Capturing of Antibodies from Perfusion Processes

Synopsis

• Translating the upstream success of continuous processing into downstream units – perfusion and chromatography
• Is scaling down the way to go?
• What equipment and analytical tools are required to breakthrough continuous DSP?

12.40
Integrated End-To-End Continuous Bioprocessing – An Industry-Wide and US Government Sponsored Initiative for Steady-State Manufacturing of Biologics Using Continuous Countercurrent Tangential Chromatography (CCTC)

Synopsis

  • Introduce integrated end-to-end continuous bioprocessing platform based on CCTC as sponsored by the NIH and FDA contracts totaling > $4 Million
  • Present recent data from protein A capture, mixed-mode bind/elute and anion exchange flow through CCTC platform testing with end-users
  • Share results from a collaborative R&D project on CCTC resin development between ChromaTan and Purolite that resulted in record high productivity of 140 grams / Liter of resin /hr for Protein A capture
  • Share vision for the future development of continuous bioprocessing from supplier point of view and discuss the important milestones and challenges aheah

CCTC is a new column-free continuous purification platform for mAbs, vaccines and other biologics, providing a single-use alternative to column chromatography. Recent multi-million dollar awards from government agencies enabled the development of a new vision for  . Chromatan and partner Purolite will share new data from multiple evaluations of CCTC for various chromatographic modalities, and present a new resin that was jointly developed specifically to increase the productivity of the CCTC platform.

12.55
Lunch & Networking

Where Are We? Biologics CM Advancements

13.55
SPOTLIGHT: Pioneering Technologies – Advanced Multi-Column Chromatography Platform

  • Gerard Gach Chief Marketing Officer, LEWA Bioprocess Technologies

Synopsis

• Showcasing continuous 2 column capture; details and data
• Sequential column operation with in-line buffer adjust columns
• Exploring the impact of integrated buffer in-line dilution from concentrates
• Demonstrating three unit modes all on the same skid – manage nearly any production scenario

14.10
Progress & Challenges in Bridging the Gap – End-to-End Continuous Processing

  • Engin Ayturk Senior Manager, Technical Development, Biogen

Synopsis

• Addressing implementation challenges for end-to-end automated continuous processing
• Evaluating early success in lab and pilot scale continuous biomanufacturing
• Reality check: Feasibility and operability – considerations and modifications to different technologies

14.40
Get it Right First Time – Designing Your Synthetic Process for CM at the Drug Discovery Stage

  • Nathan Collins Vice President, Applied Research & Technology Development, SRI Biosciences

Synopsis

• Laying a good foundation for success at early drug discovery stage to ensure selected molecule can fit with CP
• Developing the recipe for CP during synthesis design using advanced lab based multistep continuous flow automation
• Pilot project data and next steps: Modeling scale-up to accelerate drug development and processing program

15.10
Afternoon Refreshments & Networking

15.40
Planning Automation to Deliver Continuous Manufacturing Benefits

  • Bob Lenich Life Science Business Director, Emerson Automation Solutions

Enhancing Quality Control & Validation Strategy

16.10
Project Update: One Year On & Launch of Second Commercial CM Rig

  • Michelle Bailey Associate Director, Head of Validation for Continuous Manufacturing & Automation, Vertex Pharmaceuticals

Synopsis

• Discussing the lessons learnt in the first launch of CM at Vertex and challenges in the second commercial rig
• Collaborating with suppliers and CMOs for CM program build out
• Understanding regulatory inspection concentration areas for CM
• Looking beyond – what’s next?

16.30
Poster Session: Towards Model-Based Bioprocess Design: An Upstream In-Silico Model of Cell Cycle, Metabolism & Apoptosis

  • António Grilo Researcher, Biological Systems Engineering Group, Imperial College

Synopsis

• Modeling of bioprocess systems: providing a powerful tool to cope with the current QbD paradigm, the challenges imposed to the biologicals market by biosimilars and the move towards continuous biomanufacturing, and the need for time-to-market reduction
• Developing and validating an in-silico model of upstream mammalian cells biomanufacturing
• Addressing the potential of the model for process optimization, bioreactor heterogeneity description and reduction of experimental-based process development

16.45
Chair’s Closing Remarks

16.50
Close of Day One