Cambridge Healthtech Institute’s 2nd Annual

Digital Biomanufacturing

Embracing Digital Transformation in Bioprocessing

August 14-15, 2019

Industry 4.0, internet of things, big data, AI … these are words that we are seeing and hearing around us, enabling exciting developments such as autonomous cars, smart factories and connected cities. This wave of transformation is coming to the biopharm industry, promising to revolutionize the way we approach biologics development to manufacturing.

At CHI’s Digital Biomanufacturing conference, we present exciting visions and approaches to digitalize the biopharm processes, by introducing machine learning, automation, predictive modeling, data analytics and knowledge-driven tools to bioprocess development, workflow, and operations within the biopharm companies.

Final Agenda

TUESDAY, AUGUST 13

Waterfront 1AB

6:00 – 8:30 pm Recommended Short Courses*

SC8: Model-Based Solutions for Digitalization and Automation in Bioprocessing - What Data, Expertise and Software Do I Need?

Instructor:

Alessandro Butte, PhD, CEO, DataHow and Lecturer/Sr Researcher, ETH Zurich

The aim of this course is to provide an overview and advanced insight into process data characteristics and analysis methodologies. It will cover important perspectives on data organization and pretreatment, basic and advanced analysis methodologies and software solutions as well as central expertise and domain knowledge to be included into the assessment of process data. The course will combine an introduction into central concepts and their application to cases studies from industry. The goal is to reveal the large potential of data- and knowledge-driven solutions to create value from data in the bioprocessing domain.

Wednesday, August 14

6:00 - 6:45 amSeaport Fun Run/Walk (Seaport Hotel Plaza Lobby)

7:00 am Registration Open and Morning Coffee

MACHINE LEARNING AND DIGITAL TRANSFORMATION IN BIOPROCESSING

Cambridge

8:05 Chairperson’s Remarks

Cenk Undey, PhD, Executive Director, Digital Integration and Predictive Technologies (DIPT), Process Development, Amgen

8:15 OPENING PRESENTATION: Machine Learning in Bioprocess Development: Where We Are and Where We Could Go

Moritz von Stosch, PhD, Head, Process Systems Biology and Engineering Center of Excellence of Technical R&D, GSK Biologicals, Belgium

• How to ask the right questions for AI projects
• A collection of possibilities and examples of AI application for bioprocess development
• Considerations for an AI strategy
• Transformations in business models and their implications

9:00 KEYNOTE PRESENTATION: Robotic Automation and Digital Transformation to Enable High Throughput Development of Novel Biologics from Clone to Clinic

Nallakkan Arvindan, PhD, Senior Vice President, Strategic Technology Operations, Five Prime Therapeutics

From producing the entire human extra-cellular proteome (approx. 6000 proteins) for discovery screening to upstream and downstream process development for large scale manufacturing of biologics, robots play a key role in high productivity R&D operations at Five Prime. A unique digital platform developed at Five Prime automates the capture of experiment designs and data, enabling quick access to analytics and insights from clone to clinic.

9:30 Innovation in Biologics Manufacturing: Moving towards Personalized Medicines

Antonio Moreira, PhD, Vice Provost, Academic Affairs, University of Maryland, Baltimore County

The advent of personalized medicines, including cell and gene therapies, is bringing a new paradigm to the manufacture of these biological products. Rather than using large scale manufacturing facilities, these products will be manufactured in smaller volumes and will generate new challenges with supply chain logistics and will bring new regulatory considerations to be addressed. This presentation will highlight these challenges and opportunities and discuss some of the innovations being developed.

10:00 Coffee Break in the Exhibit Hall with Poster Viewing 

INDUSTRY 4.0

Cambridge

10:45 Applying Industry 4.0 Concepts to Biologics Manufacturing

Richard D. Braatz, PhD, Edwin R. Giilliland Professor of Chemical Engineering, Department of Chemical Engineering, Massachusetts Institute of Technology

Industry 4.0 refers to an approach for manufacturing technologies that leverages process automation, data analytics, and systems integration. This talk will describe the application of concepts from Industry 4.0 to creating a streamlined process development workflow for the manufacturing of biologics. Specific strategies are described, including the use of small-scale technologies for high-speed process development, modular unit operations with integrated process control and monitoring systems, and smart process data analytics.

11:15 Intelligent Predictive Monitoring and Control of Biopharmaceutical Manufacturing in the Age of Industry 4.0

Cenk Undey, PhD, Executive Director, Digital Integration and Predictive Technologies (DIPT), Process Development, Amgen

We are living through exciting times where advances in infotech and biotech are nicely converging. Infotech sees digital accelerators in terms of high performance computing, cloud-based systems, big data and wireless sensors to name a few. Biopharm industry continues to evolve by introducing more live modalities, establishing continuous biomanufacturing platforms, and generating ever increasing data from development to manufacturing. We will discuss state-of-the-art applications from AI, sensors, in silico modeling and systems theory to advance biomanufacturing.

11:45 Beyond Bioprocessing 4.0: The Convergence of IT, OT and Processing Technologies to Enable a Smart Facility

Joshua Hays, B.S., Associate Director of Commercial Strategy, BioContinuum™ Platform, MilliporeSigma

The cost of manufacturing mAbs is a major hurdle towards availability for patients. Facility costs, utilization and labor contribute to the cost of these critical medicines. Digital technologies have had transformative impacts on other industries’ manufacturing operations and apply to today’s biopharma evolution. Multiple unit operations will be presented to illustrate incremental improvements achievable today, and what the future looks like with the convergence of Operational Technology (OT), Information Technology (IT) and existing processing technologies.

12:15 pm Enjoy Lunch on Your Own

1:00 Dessert Break in the Exhibit Hall with Poster Viewing

AUTOMATION, MODELING AND DATA ANALYTICS IN PROCESS DEVELOPMENT AND WORKFLOW

Cambridge

1:45 Chairperson’s Remarks

Antonio Moreira, PhD, Vice Provost, Academic Affairs, University of Maryland, Baltimore County

1:50 Hybrid Models: The Best of Both (Mechanistic & Empirical) Worlds to Accelerate and De-Risk Process Development

Christian Airiau, PhD, Head, Data Science, Biologics Development, R&D, Sanofi

Process optimization through the use of modeling is a key objective to accelerate and de-risk process development. A critical step to improve our process development, process monitoring and process control is to understand the strength and limitations of each types of modeling approaches. Using the most relevant empirical approaches - from DoE to Multivariate Analysis - and the mechanistic understanding we have about our processes – Kinetics, thermodynamics – we are rethinking the way we conduct process development.

2:20 Digitization of Raw Material Data and the Application of Data Analytics to Better Understand and Control Variation

Susan Burke, PhD, Director, Process Development, Amgen

This talk will review the challenges and opportunities associated with the digitization of Raw Material related data and how access to that data can then be used to understand and potentially control the impact of Raw Material variation on process and product variation during the manufacture of biopharmaceutical products.

2:50 Bioprocess Research of Tomorrow: Automated Workflows, Model-Based Analytics and Data-driven Decisions

Tobias Grosskopf, PhD, Scientist, pRED Large Molecule Research, Roche Diagnostics GmbH

We have built a highly automated small-scale cell culture landscape for cell line screening and upstream processing in the challenging field of development of complex antibody therapeutics. In my talk I will show our strategies and approaches of digitalization to maximize the utilization of the huge amount of data derived from automated systems.

3:20 Implementation of an Integrated E2E Bioprocess Development Workflow Platform at Celgene

James Daly, Research Associate, Biologics, Celgene

Developing large-molecule therapeutics is a challenging and costly task, as diverse and complex R&D activities spanning cell line development, upstream and downstream process development, and scale-up for GMP manufacturing need to be integrated. In this presentation, we share Celgene’s strategy for implementation of an enterprise end-to-end (E2E) workflow platform based on Genedata Bioprocess®, with the goal of integrating and streamlining development activities to support a growing number of internal biologics programs.

3:50 Refreshment Break in the Exhibit Hall with Poster Viewing 

4:45 Plenary Keynote Session View details

6:00 A Taste of New England Reception in the Exhibit Hall with Poster Viewing 

7:00 End of Day

Thursday, August 15

6:00 - 6:45 am Namaste@#BPSMT (Seaport Hotel Plaza Lobby)

8:00  Registration Open and Morning Coffee

DATA AND KNOWLEDGE-DRIVEN TOOLS FOR SMART FACILITIES AND PROCESS CONTROL

Cambridge

8:25 Chairperson’s Remarks

Christian Airiau, PhD, Head, Data Science, Biologics Development, R&D, Sanofi

8:30 Biopharmaceutical Process Models in the Digital Age - How to Make Value Out of Data

Alessandro Butte, PhD, CEO, DataHow, and Lecturer & Sr Researcher, ETH Zurich

Several important trends have been observed in bioprocessing towards more robust and automated operations. Based on industrial case studies this presentation will highlight the enabling role of advanced process modeling for bioprocess digitalization and automation. Thereby, the importance of several model-assisted steps in data organization, alignment, pretreatment and eventually analytics will be discussed to transfer data through information to valuable knowledge and decision support.

9:00 NEW: Selected Poster Presentation: Digital Bioprocessing Scale-Up: The Impact of Instrument and Software Integration

Jesus Zaragoza, Solutions Architect, Engineering, TetraScience Inc.

Scientists and informatics teams place a heavy reliance on the manual collection, transfer, manipulation, storage, and reporting of their instrument data. This lack of automation slows processes, inhibits scalability, and can jeopardize data integrity. We have designed and developed a new approach to collect and manage data from a bioprocess workflow. In this poster, we detail the workflow pre- and post-integration, highlighting updated data flows and resulting impacts. Specifically, this digital bioprocess workflow offers automated data capture, aggregation, reporting, and downstream consumption by software used in industrial bioprocess environments. Additionally, the process includes collecting time-stamps and audit trails, and real-time reporting and alerting on environmental parameters (pH, temperature, etc.) and their variance. Lastly, our approach takes into consideration ALCOA principles in order to ensure data integrity.The implementation of these instruments and software integrations resulted in significant time savings, enabled advanced analytics, and improved data integrity. Our hope is that this poster serves as a blueprint to those pursuing a digital bioprocessing strategy. Instrument and software integration is a crucial step in automating and accelerating today's bioprocess and drug discovery.   

9:30 NEW: PANEL DISCUSSION: Enabling Digital Integration - Where Do You Start? What Tools/Software Do You Need?

Speakers of the Day

10:00 Coffee Break in the Exhibit Hall with Poster Viewing 

10:45 Biopharmaceutical Process Model Evolution – Enabling Process Knowledge Continuum from an Advanced Process Control Perspective

Saly Romero-Torres, PhD, Senior Manager, Advanced Data Analytics, Biogen

Biogen is adopting modeling maturity models similar to the ones used by high tech industries such as semiconductors, electronics and AI. The focus of this maturity model is to ensure that a plan for model evolution is conceived, and socialized, among SMEs and regulatory agencies early on during process development. This plan is crucial particularly when implementing data driven models that rely on process experience. A well-planned modeling continuum should allow the pharmaceutical industry to realize the benefits from modeling activities early on, while evolving into more mature prescriptive controllers that operate within Established Conditions (EC) and are potentially implemented through Post-Approval Change Management Protocols (PACMPs).

11:15 Data-Driven Initiatives for Optimization of Next-Generation Biomanufacturing

Francisca Gouveia, PhD, Senior Process Expert, Manufacturing Science and Technology, Novartis Pharma S.A.S.

An effective development and manufacturing strategy for biologics should be based on a solid foundation of knowledge and requirements. Process Analytical Technologies (PAT) combined with data-driven decision making (e.g., by Multivariate Data Analysis, MVDA) have the potential to add significant improvements to existing processes/products while maintaining a connection to business needs. In this presentation, examples of PAT/MVDA applications will be used to demonstrate how these approaches can support continuous improvement efforts in biologics manufacturing.

11:45 Data at Your Fingertips: The Benefits of an Integrated Informatics System

Scott Kincaid, Msc, Informa Deployment Lead, Pfizer

With the increase in the amount of data from process monitoring and increase analysis frequencies, an informatics system that can pull data from disparate systems and organize it to be ready for analysis is more important than ever before.  This talk will cover the key elements to include in the design of an informatics system and the benefits that can be achieved.

12:15 pm Enjoy Lunch on Your Own

1:15 Refreshment Break in the Exhibit Hall with Last Chance for Poster Viewing 

1:55 End of Conference