Jan 30 – Feb 1, 2018
Boston, MA

Day One
Wednesday January 31, 2018

Day Two
Thursday February 1, 2018

08.00
Coffee & Registration

09.00
Chair’s Opening Remarks

Continuous Manufacturing: Translating Sciences into Business Strategy

09.15
Continuous Bioprocessing – One Tool in the Toolbox

  • Lotta Molander Senior Global Product Manager, GE Healthcare Life Sciences

Synopsis

  • Will continuous or hybrid approaches, using a combination of batch and continuous unit operations, be a solution for your process?
  • Process development, pilot scale and large-scale manufacturing solutions are available
  • Highlight GE Healthcare’s solutions to support process intensification initiatives

09.30
Panel Discussion: Establishing a Winning Business Case for Investment

Synopsis

This interactive panel discussion will be led by Lisa Graham, CEO & Founder, Alkemy Innovation to delve into the importance of bridging science with business strategy during continuous manufacturing evaluation and implementation. Audience will also have the opportunity to ask panelists questions at the end of this session.

• 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
• The importance of bridging the gap between science and business strategy – example of PAT choice and quality monitoring, when and why should you conduct business analysis on technology choice?

 

10.30
Speed Networking & Coffee Break

Where Are We? Biologics CM Advancements

11.45
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

12.15
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?

12.45
Scalable Technologies for Process Intensification in the Factories of the Future

  • Marcus Peiker Process Development Consultant, Sartorius Stedim Biotech GmbH

Synopsis

  • Can continuous and intensified bioprocessing promise smaller facilities, reduced scale-up risks, and more consistent product quality and higher throughputs?
  • Technical challenges for practical implementation
    • Upstream: what are the tools for high throughput intensified and continuous cell
      culture development
    • Downstream: robust solutions required for MCC product capture
  •  The need to advanced PAT controls to inter-connect unit operations, balancing flow and feedback loop
  • Discuss how latest innovations can address the above challenges through real life examples and add value with cost modelling data

13.15
Lunch & Networking

Where Are We? Biologics CM Advancements

14.15
SPOTLIGHT: A Simple Design to a Flexible 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

14.30
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

15.00
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

15.30
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.

15.45
Afternoon Refreshments & Networking

Enhancing Quality Control & Validation Strategy

16.15
Planning Automation to Deliver Continuous Manufacturing Benefits

  • Bob Lenich Life Science Business Director, Emerson Automation Solutions

Synopsis

• How automated process control can offer greater flexibility and reassurance to continuous manufacturing
• Success story and future challenges

16.45
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?

17.15
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

17.30
Chair’s Closing Remarks

17.35
Close of Day One