Cambridge Healthtech Instituteの第4回年次会議
Smart Biomanufacturing & Digitalization
2023年8月16 - 17日、EDT（米国東部標準時）
Registration and Morning Coffee7:30 am
KEYNOTE SESSION: DIGITAL INNOVATIONS DRIVING BIOTHERAPEUTICS DEVELOPMENT
Digital Innovation in Transforming Molecules of Today into the Medicines of Tomorrow
We generate significant amount of data during development and manufacturing of biopharmaceutical therapeutic proteins. Managing data and applying predictive/prescriptive analytics including artificial intelligence and in silico modeling tools right from the start throughout the product development lifecycle into manufacturing is critical for seamless data flow, robust design and accelerating the development activities. Digital innovation paired with digital mindset is a significant enabler bringing life changing medicines to patients. Strategies and practical industrial examples will be discussed.
- Convergence of biotech and infotech revolutions to create speed, efficiency and more
- Enabling seamless data flow paired with AI: Challenges and prospects
Presentation to be Announced8:30 am
Preparing for the Smart Factories of the Future: CDER's Journey
The advanced technologies and manufacturing approaches needed to enable smart factories may have the potential to deliver higher output, increased manufacturing safety, improved quality, better value, increased agility, additional flexibility, and reduced waste. The presentation with share CDER’s experience to date engaging with manufacturers on digital technologies through the Emerging Technology Team. CDER’s initiatives on evaluating the existing regulatory framework in the context of digital technologies and AI will also be discussed.
Coffee Break in the Exhibit Hall with Poster Viewing10:00 am
AI/ML & DIGITALIZATION - IMPACT AND OUTLOOK FOR BIOLOGICS MANUFACTURING
AI/MLとデジタル化 - バイオ医薬品製造に対する影響と展望
Hybrid Model and Machine Learning Enable Efficient Knowledge Generation for Bioprocess Development of mAbs and New Modalities
In this presentation, we show how advanced machine learning and hybrid modeling approaches can be exploited to significantly improve process understanding, performance, and automated operation as digital twins. All presentations will be centered on industrial implementation examples for mAb, cell & gene therapy, and mRNA processes with numerous big pharma and CDMO partners allowing to quantify efficiency gains in process development.
The Short-Term and Long-Term Outlook of AI-Centered Technologies and Digital Integration in Biomanufacturing
- Which technologies are used today and how?
- What value is expected from these technologies?
- What are the main challenges to consistently drive value from data?
- How can business cases be defined leading to success stories?
Sponsored Presentation (Opportunity Available)12:10 pm
Refreshment Break in the Exhibit Hall with Poster Viewing12:40 pm
DATA INFRASTRUCTURE & MANAGEMENT
Advancing Digital and Data Infrastructure for Bioprocess Development
Implementing a framework for unified IT/OT infrastructure and data management is foundational to digital process development. This framework of connected systems, data and analytics can be harnessed to allow end-to-end process visibility, improve comparability and predictability across scales and products, and thus enhance productivity and quality. A holistic & pragmatic strategy will be discussed to advance data architecture, governance, integration, sharing and analytics consumption in support of our core mission to bring new medicines to patients
A Digital Transformation Journey in Process Development - Building Automated Data Flows, from Equipment to eLN to Advanced Analytics
Sanofi CMC/Process Development is implementing a comprehensive Digital Transformation program to improve our productivity and reduce our development timelines. We are deploying a standardized digital workflow across our development sites globally (target: 2,000 users) and building automated data access to ensure scientists can document, visualize, and analyze their experimental work. We will discuss the progress, successes, and pain-points encountered by the development teams as we progress towards our digital ambition.
Sponsored Presentation (Opportunity Available)2:30 pm
Refreshment Break in the Exhibit Hall with Poster Viewing3:00 pm
PLENARY KEYNOTE: LEADING TO TOMORROW'S ADVANCES
Current and Future Trends in Biomanufacturing of New Modalities
Using exosomes as an example, this presentation examines the current and future trends in biomanufacturing, and the technologies needed to manufacture emerging modalities at scale. Traditional biomanufacturing methods do not provide the industrialized, commercially scalable, highly efficient and reproducible manufacturing process essential for this new class of biotherapeutics- so we built it from the ground up.
The Digitalization of Biomanufacturing
A fully instrumented testbed is described for the end-to-end integrated and continuous manufacturing of monoclonal antibodies. The testbed consists of parallel bioreactors, simulated moving bed chromatography systems for capture and polishing, bespoke viral inactivation, and a MAST auto-sampling system. Experimental results are compared with a digital twin for continuous runs lasting 30 to 60 days each, which include variations in metabolites and glycosylation profiles in designed experiments. The increased consistency in the glycosylation profile of the monoclonal antibodies being produced is quantified when going from batch to semi-batch to perfusion mode, and when moving from start-up to quasi-steady conditions.
Networking Reception in the Exhibit Hall with Poster Viewing5:00 pm
Close of Day6:00 pm
Registration and Morning Coffee7:30 am
DIGITAL TWIN AND DATA SCIENCE
Holistic Experimental Design and Deployment Strategies of Digital Twins for Accelerating Bioprocess Life-Cycling
Acceleration of commercialization of biologics including the filing of a robust control strategy is of utmost importance for biosimilars up to new modalities. Digital twins capture CMC knowledge and allow multiple deployments. We will show
- How end-to-end digital twins can help saving 50% of experimental effort by incorporating drug substance specification when designing unit operations and
- How real time application allows for prediction and control on process performance
Application of Physics-Informed Neural Networks in Real-Time Cell Culture Bioreactor Modeling
Monitoring and control of viable cell density, metabolite concentration, and titer is critical for optimizing the development and manufacturing of cell cultures. A real-time bioreactor model has been developed using the novel modeling approach, physics-informed neural networks. This framework combines the power of AI with the robustness of mechanistic laws to reliably predict key product attributes. A proof-of-concept of this model has been implemented and tested in a bench-scale bioreactor.
Coffee Break in the Exhibit Hall with Poster Viewing9:00 am
Breakout discussions provide an opportunity to discuss a focused topic with peers from around the world in an open, collegial setting. Select from the list of topics available and join the moderated discussion to share ideas, gain insights, establish collaborations or commiserate about persistent challenges. Please visit the breakout discussions page on the conference website for a complete listing of topics and descriptions.
Monitoring, Modeling, and Controlling the Basis for Automated and Autonomous Biomanufacturing
The long-term vision of biomanufacturing is autonomous bioprocessing. To achieve this state, it is necessary to automate bioprocesses, which require sensors to control a manufacturing system. Currently, for a lot of quality/process parameters sensors are not available and soft sensors and self-learning algorithms must be applied. The state-of-the-art of monitoring and control of bioprocesses will be provided and to which extent integrated continuous biomanufacturing necessitates autonomous bioprocessing.
Process Modeling for Ultrafiltration and Formulation
Model-based approaches in the biopharma industry have the potential to accelerate decision-making, optimize the product to market time, and reduce costs. In silico representation of manufacturing processes is becoming easier thanks to analytical tools, process modeling software, and machine learning algorithms. In this contribution, we demonstrate the use of model-based approaches for decision-making for ultrafiltration and formulation processes.
Sponsored Presentation (Opportunity Available)11:30 am
Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own12:00 pm
Refreshment Break in the Exhibit Hall & Last Chance for Poster Viewing12:30 pm
PAT, APC AND AUTOMATION
PAT Deployment in GSK Vaccine from R&D to Manufacturing
Biopharmaceutical industry traditionally relies on pharmaceutical manufacturing practices to monitor processes and release products. The use of Process Analytical Technologies (PAT) can improve the process monitoring and control and at the same time increasing the process understanding and modelling capabilities. This talk examines the possible PAT application to vaccine processes using a phase- and technology-appropriate approach to reach a fully implemented in-line monitoring (ILM).
PAT and Automation for Robust Upstream Stem Cell Processing
Advanced therapy medicinal products (ATMPs) require new manufacturing technologies for industrialization. Especially allogenic cell therapies require novel approaches to move from highly manual cell cultivation processes towards automated and closed systems that allow industrial scale-up or scale-out, while ensuring sufficient process analytical technologies and interfaces for real-time monitoring and control.Here we will present our recent developments in PAT and automation for transferring manual adherent iPSC cultivation processes to highly automated and fully closed cultivation systems. New PAT methods allow for rapid in-process testing of parameters specific to these new modalities and in combination with our robotized cell cultivation platform, the transition from a laboratory process to a closed and data-driven industrialized process is enabled.
Enabling Global Operations with Realtime Sensing: A Case Study in Digital Product Management
In this session, you will learn about an important digital transformation effort at Amgen focused on delivering insights to senior leadership. The presentation will focus on a key use case for the global operations function (process development, manufacturing, quality, supply chain, etc.) along with the practice of digital product management. Learn how this approach improves agility as well as the nature of challenges that arise.
Networking Refreshment Break2:40 pm
Smart Process Analytics for the Prediction of Critical Quality Attributes in End-to-End Batch Manufacturing of Monoclonal Antibodies
For many modern biopharmaceutical processes, manufacturers develop data-driven models using data analytics/machine learning methods. The challenge is how to select the best methods for a specific dataset to construct the most accurate and reliable model. This presentation describes the application of smart process data analytics software to industrial end-to-end biomanufacturing datasets for monoclonal antibody production to automate the determination of the best DA/ML tools for model construction and process understanding.
Accelerated Raman Development for Implementation at Large-Scale
Raman spectroscopy has been utilized for many different applications in cell culture bioprocesses, however, the adoption of PAT into commercial environments has been slow. A toolbox methodology will be shown with the aim of reducing time to implement Raman spectroscopy applications in cell culture processes.
PAT and Process Control for Cell and Gene Therapy Products
Developing a robust digital infrastructure that supports the dynamic aspect of cell and gene therapy development from research through to manufacture is an industry challenge. It is crucial to integrate equipment and software into a contained digital workflow for controlling and characterising a process, delivering finer parameter control and significant time-savings.
Close of Summit4:25 pm