Cambridge Healthtech Institute’s Inaugural
Manufacturing 4.0
Where A.I. Meets Bioprocessing
August 15-16, 2018
You have no doubt heard of Industry 4.0, a name that refers to the current trend of automation and data exchange in manufacturing technologies. it includes cyber-physical systems, internet of things, cloud computing and cognitive computing. "Smart Factory"
is a brain child of Industry 4.0.
Some of the new technologies that are being explored in smart factories include systems and sensors that monitor physical processes; use of connected devices over the internet of things to communicate and cooperate with each other and the humans in real
time, and via cloud computing, data is stored and accessible to internet and external users across the value chain.
CHI’s Inaugural Manufacturing 4.0 invites speakers to share their vision on these technologies which promise to transform and revolutionise biomanufacturing, illustrate examples where they are applying these digital technologies
in their manufacturing process, and discuss plans and strategies to take advantage of these new opportunities.
Final Agenda
Wednesday, August 15
7:00 am Registration Open and Morning Coffee (Grand Ballroom Foyer)
8:05 Chairperson’s Remarks
Robert Dream, PE, CPIP, Managing Director, HDR Company
8:15 KEYNOTE PRESENTATION: Disruptive Innovations to Lower Healthcare Costs
Govind Rao, PhD, Professor and Director, Center for Advanced Sensor Technology, UMBC
Rising healthcare costs are a major threat to the economy. While much of the focus has been on healthcare access, not much attention has been paid to reducing healthcare costs. We demonstrate novel technological approaches that promise to harness
the revolutions demonstrated by the consumer electronics and computer industry that show that quality and cost are not synonymous. We demonstrate disruptive low-cost diagnostic and therapeutic technologies that can empower caregivers with novel,
low-cost point-of-care solutions.
9:00 Cell Free Synthesis: A Highly Disruptive Technology for Manufacture of Personalized/Targeted Medicines
Daniel G. Bracewell, PhD, CEng, MIChemE, Professor, Bioprocess Analysis & Doctoral Admissions Tutor,
Department of Biochemical Engineering, University College London
The pipeline of personalized and targeted medicines covers a wide range of treatment types including cell and gene therapies, vaccines based on peptides or proteins, and protein-based therapies. These increasingly diverse and smaller market size products
require improved agility and productivity in process design if manufacture is to be affordable. We examine the potential of cell free synthesis, to address this need, focusing on protein-based therapeutic products.
9:30 Precision Health and 3D Bioprinting: A Head to Toe Workflow
Paul C. Goodwin, MSc, Scientific Director, GE Healthcare
Current bioprocess manufacturing focuses on biologic replacement therapies and monoclonal antibodies. We are at the beginning of a new wave of therapies wherein the cell is the therapy. We have seen investments and advancements in T-cell therapies,
but if they only address immunotherapy, we will have missed a larger opportunity. We present here the vision of a workflow to address the need to generate replacement structures, tissues, and organs that are living, bespoke, autologous, and regulated.
10:00 Coffee Break in the Exhibit Hall with Poster Viewing (Grand Ballroom)
10:45 Accelerating Development of Medical Countermeasures for the Warfighter: Platform Technologies as Critical Tools to Reduce Developmental Risk and Costs, and Enable Rapid Responsiveness to Novel Threats
Christopher Earnhart, PhD, Joint Product Lead, PRISM; Joint Program Executive Office
for Chemical, Biological, Radiological and Nuclear Defense, Department of Defense
The DoD PRISM (Platforms for Rapid Integrated Solutions for Medical Countermeasures) office is investigating mechanisms to accelerate medical countermeasure (MCM) development and fielding, primarily by using platform technologies. PRISM is adapting
platforms to meet Warfighter requirements and provide MCMs against known threats at reduced cost, schedule, and developmental risk. Additionally, PRISM is implementing innovative processes, technologies, and regulatory interactions to enable
response within an operationally relevant timeframe to emerging threats.
11:15 Streamlining the Cell Therapy Workflow with Silicon Chip Technology
Sunil Gangadharan, PhD, Strategic Partnerships, Life Science Technologies & Smart Electronics
Applications, imec
A major hurdle to scale up the market of cell therapies is the cost and complexity of the workflow. We propose a novel approach based on a standardised workflow which will be easy to use, reliable and reproducible. Using silicon chip technology,
fully integrated solutions can be built, combining microfluidics, photonics-based biosensors, PCR, and single cell manipulation. We will present a portfolio of technologies which will be the building blocks for bioprocessing and delivery of
future personalised therapies.
11:45 Digital Manufacturing Use Cases from Different Industries: Applicability to BioPharma
Namit Mehta, PhD, Director, Health Industries - Operations Strategy, Strategy& (Part of the PwC Network)
Digital manufacturing is a solution geared towards solving traditional supply chain challenges through application of cutting edge technologies like Big data, 3D printing, IoT, AI etc. These platforms are creating positive impacts measurable in
both the top line & bottom line of companies. We are looking at a few success stories from different industries where application of such technologies have given remarkable results. We are also gauging the application of the same towards
the BioPharma industry where they are geared to solve problems across the value chain.
12:15 pm Enjoy Lunch on Your Own
1:00 Session Break
1:45 Chairperson’s Remarks
Michael Sokolov, PhD, Postdoctoral Fellow and Lecturer, Institute of Chemical and Bioengineering, ETH Zurich and Co-Founder & COO, DataHow
1:50 Industrie 4.0: What’s Next
Robert Dream, PE, CPIP, Managing Director, HDR Company
Industry 4.0 can solve key challenges facing manufacturers – from extreme supply, demand, and design variability, to emerging markets of one, to the growing need for rapid innovation. Leveraging the principles of Industry 4.0 –
and its enabling technologies to automate, integrate, and optimize manufacturing processes – companies can shorten cycle times, improve product quality, and implement efficiency across their operations, as well as grow the manufacturing
of highly customized products on a global scale.
2:20 Industry 4.0 and Continuous Biopharmaceutical Manufacturing
Samet Yildirim, MSc, MBS, Manager, Technology & Innovation, Global Technology Management, Boehringer
Ingelheim Fremont, Inc.
This talk will address why integrated continuous manufacturing is essential to move into the Industry 4.0 and how we can utilize digital technologies in biopharma manufacturing. Questions explored include: What industrial revolution are we
currently in? Why disposable, integrated and continuous process is essential for industry 4.0? Highly automated and modular flexible facilities are the future of biomanufacturing. Knowledge management, machine learning and big data are
essential parts of the game. How can 3D printing be part of disposable processes?
2:50 Breakout Discussions
Big Data in Bioprocessing – Vice or Virtue?
Moderator: Michael Sokolov, PhD, Postdoctoral Fellow and Lecturer, Institute of Chemical and Bioengineering, ETH Zurich and Co-Founder & COO, DataHow
The Path of Least Resistance, and the Adoption of New Technology
Moderator: Eben Crawford, Process Engineer, Celldex Therapeutics
- Where do software solutions fit into process development?
- How do you see continuous processing effecting plant design?
- Why fix what isn't broken? How do you see new technologies displacing legacy manufacturing?
- What manufacturing step would you like to see changed the most?
- How will consolidation in the industry affect manufacturing?
3:50 Refreshment Break in the Exhibit Hall with Poster Viewing (Grand Ballroom)
4:45 Plenary Keynote Session (Constitution Ballroom)
4:45 pm Chairperson’s Remarks
John Sterling, Editor in Chief, Genetic Engineering & Biotechnology News (GEN)
4:50 Digital Transformation to Advance Next-Generation Biomanufacturing through
Data Integration and Analytics
Jerry Murry, PhD, Senior Vice President, Process Development, Amgen
Hundreds of millions of data points are currently generated through the development and execution of biopharmaceutical processes. It is expected that the volume and complexity of biomanufacturing data is set to grow exponentially as developers
and manufacturers integrate novel sensors, smart materials, process analytical technologies and process automation into laboratories and manufacturing plants. This presentation will describe the value associated with a comprehensive digital
strategy incorporating a structured data integration and analytics platform inclusive of AI, predictive modeling and visualization, and how digital transformation can advance next-generation biomanufacturing.
5:20 Driving Change in Biomanufacturing through Innovation in Processes, Technologies and Operations
Eliana Clark, PhD, Vice President, International Manufacturing Operations, Biogen
A critical step in meeting the demand of biologic production worldwide involves implementing disruptive manufacturing technologies, processes and capabilities. This talk will use Biogen’s new manufacturing site in Switzerland, due
to go online in 2019, as an example to demonstrate the new processes, operational models and technologies being adopted to drive value through innovation and deliver new medicines in areas such as Alzheimer’s.
5:50 End-to-End Solutions Considering New Trends in Biomanufacturing
Guillaume Plane, MSc, MBA, Manager, Global Development, Biodevelopment Solutions, MilliporeSigma
The presentation will get into the current state of biomanufacturing, from DNA to market approval, considering the way a key supplier can support drug makers to the fullest, thanks to a deep understanding of the trends that could affect
our industry in the midterm, including growth of the pipelines, strengthening of regulations, and acceleration of timelines, for development as well as for the set-up of capabilities. Some thoughts and ideas will be proposed to consider
commercial manufacturing with single-use equipment.
6:25 Close of Plenary Keynote Session
6:25 10th Anniversary Champagne Celebration in the Exhibit Hall with Poster Viewing (Grand Ballroom)
7:30 End of Day
Thursday, August 16
8:00 am Registration Open and Morning Coffee (Grand Ballroom Foyer)
8:25 Chairperson’s Remarks
Daniel G. Bracewell, PhD, CEng, MIChemE, Professor, Bioprocess Analysis & Doctoral Admissions Tutor, Department of Biochemical Engineering, University College London
8:30 Mastering the Digital Challenge in Bioprocessing through Machine Learning and Hybrid Modeling
Michael Sokolov, PhD, Postdoctoral Fellow and Lecturer, Institute of Chemical and Bioengineering,
ETH Zurich and Co-Founder & COO, DataHow
Following the advanced examples of process digitalization and automation in industries such as automotive, several important trends could be observed in the biopharmaceutical domain. In particular, continuous bioprocessing and continuous
data acquisition as well as the utilization of data- and knowledge-driven tools for process analysis and control thrive towards the standards and goals of industry 4.0. Based on industrial case studies this presentation will highlight
the important roles of advanced process modeling for bioprocess digitalization.
9:00 Model-Based Tools for Automated Bioprocess Development
Mariano Nicolas Cruz Bournazou, PhD, Research Associate, Bioprocess Engineering,
Technische Universität Berlin
The internet of things in biotechnology will be always coupled with experimental activities to validate and re-adjust models to the reality of living systems. Thus robotic laboratories have to be intelligent when designing experiments
and learning from the data. We present an integrated intelligent laboratory for rapid phenotyping of biosystems including: easy interaction of all devices, experimental design programs tailored for robotic LHS, online optimization
algorithms that enable an optimal operation of the robots, and advanced control methods to assure the correct operation of the facilities.
9:30 Integrated E2E Workflow System for Data- and Knowledge-Driven Process Development
Amanda Fitzgerald, PhD, Senior Scientific Consultant, Biologics, Genedata
We present an E2E system for the development of manufacturing processes for biotherapeutics supporting workflows from post-discovery to commercial manufacturing. The system integrates the development and assessment of cell lines, upstream
and downstream processes, corresponding raw materials, and analytical tests. We show how the system tracks the full history of all manufacturing cell lines, as well as USP and DSP batches, and enables automation via integration
with liquid handling systems, bioreactors, and other instruments.
10:00 Coffee Break in the Exhibit Hall with 2nd Session Poster Winner Announced (Grand Ballroom)
10:45 Data Mining Benchtop Experiments for Realtime Manufacturing Analysis and Facility Development
Eben Crawford, Process Development Engineer, Celldex Therapeutics
In a fast-paced manufacturing environment where quality is paramount to success, having predictive analytical methods can help detect complications before they can persist. Using the same model, new technologies and process improvements can be evaluated before implementation to investigate economic viability.
11:15 CLOSING PANEL DISCUSSION: Advance Technologies and Its Impact on Manufacturing
Moderator: Robert Dream, Managing Director, HDR Company
Industrie 4.0 involves the complete automation and computerization of the manufacturing processes, utilizing the collective potential of computerization and automation to revolutionize how the manufacturing industry works. The major
technologies that would be contributing to Industrie 4.0 include IoT (Internet of Things), Cyber-physical systems, Cloud Computing all together creating "Smart Factory". Advanceent of technologies and utlizing Industrie 4.0 will
impact:
- Big Data
- Improved production efficiency
- Smart organization
- Improved quality of products and services
- Better control of the industrial processes
- Sufficient data for better decision making
- Easier standardization
12:15 pm Enjoy Lunch on Your Own
1:15 10th Anniversary Cake Break in the Exhibit Hall with Last Chance for Poster Viewing (Grand Ballroom)
1:55 End of Conference