Conference Day One
7:45 am Registration & Morning Coffee
8:45 am Chair’s Opening Remarks
Real-Time Data for Enhanced Process Modification & Continuous Manufacturing
9:00 am The Highs and Lows of Monitoring a Continuous Small Molecule Process
Synopsis
- Challenges in obtaining offline data to calibrate PAT data to achieve automated inline monitoring
- Assessing the value of soft sensors in continuous manufacturing: advancements and challenges
9:30 am Enhancing Product Output & ROI through Optimized Quality Control for Streamlined Release Time
Synopsis
- Understanding QC procedures to streamline testing processes and reduce release time
- Optimizing real time data for continuous manufacturing to minimize waste and increase ROI
- How PAT can be implemented into biologics to accelerate progress
10:00 am A Quality by Design Approach with Laser Force Cytology™ Real-time Predictive Analytics
Synopsis
- Advanced bioanalytics are becoming a vital component of a successful QbD biomanufacturing program, where accurate and precise real-time data hold the keys to improved production consistency and product quality
- Showcasing technology which couples advanced analytics with robust multivariate data insights to enable a host of machine learning strategies that drive advanced workflow efficiency for real-time bioprocess monitoring and quality control strategies
- Discussing rapid process optimization enabled through real-time analytics, real-time process knowledge opening the door to improved product consistency and Quality by Design approach delivering significant improvements in both process and resource efficiency through highly predictive analytics
10:30 am Morning Coffee Break & Speed Networking
Synopsis
- Speed networking is the ideal opportunity to get face-to-face time with many of the brightest minds working in PAT and introduce yourself to the attendees that you would like to have more in-depth conversations with. Benchmark against industry leaders and establish meaningful business relationships to pursue for the rest of the conference and beyond.
Implementing PAT in Facilities & QC Teams for GMP Application
11:30 am Panel Discussion: Evaluating Bottlenecks with Regulatory Acceptance of PAT in Real World Applications
Synopsis
Regulatory agencies have been promotive of PAT application to improve product quality, however adoption by industry has been slower than expected, this panel will discuss common bottlenecks and misconceptions with regulatory approval for PAT in GMP environments:
- The application of new equipment hardware and software in regualted environments
- Collaborative approaches in proactive engagement with regulatory authorities for successful PAT implementation
- Accelerating regulatory approval for PAT technologies through robust validation and qualification
- Optimizing documentation and standard operating procedures (SOPS) for effective PAT implementation in a GMP environment
12:30 pm Streamlining Potency Assay Development in Cell & Gene Therapies: from Pre-IND to BLAx
Synopsis
- Phase-appropriate matrix approach towards potency assay development for CGTs
- Identifying technical challenges & accounting for criticality ni potency assay development for CGTs
- Regulatory & CMC considerations in CGT potency assay development; from pre-IND to BLA
1:00 pm Controlling Bioprocesses with In-line & On-line Process Analytical Technology (PAT) Tools
Synopsis
Data from PAT tools serve as a valuable resource for controlling bioprocesses, enabling operators to make informed decisions based on real-time measurements of key parameters, thus facilitating rapid adjustments and interventions that maximize productivity, yield, and product quality. In this talk we will highlight two use cases focused on the implementation of PAT tools for bioprocess control:
- Discussing the use of Raman spectroscopy to monitor glucose levels in a bioreactor and trigger automated addition of feed to maintain the desired concentration
- Exploring the implementation of automated sampling combined with HPLC to trigger automated column switching for continuous removal of aggregates in DSP
1:30 pm Networking Lunch
Revolutionizing Process Control & Predictive Modelling to Fast Track Material to the Clinic
2:30 pm Discussing the Integration of Process Control & Process Analytical Technologies to Leverage Predictive Values & Improve Workflows
Synopsis
- Expediting process development with integrated techniques: Leveraging PAT tools for predictive modeling and process control
- Harnessing soft sensor and inferential data-driven models for predictive modeling in pharmaceutical manufacturing
3:00 pm Process Analytical Technology for Real-time Decision Making
Synopsis
- Deploying Raman spectroscopy-based PAT in a mAb production workflow to enable real-time detection and control of important process parameters and performance through a reliable process.
- Real-time in-line metabolite monitoring’s in upstream bioprocessing and real-time in-line quantification of protein concentration during ultrafiltration/diafiltration (UF/DF)
- Demonstrating predictive chemometric model transferability across multiple cell lines
3:30 pm Afternoon Networking Break
Next Generation Model Development Strategies
4:00 pm Leveraging AI for Enhanced Process Control & Data-Driven Decision Making in Manufacturing
Synopsis
- Creating a process control system/integrated system using AI to optimize the control process, and improve efficiency and accuracy
- Using historical data to predict and monitor behavior of a new cell line to reduce costs and/or optimize data driven decision making
4:30 pm Recent Advancements in Raman Spectroscopy for Bioprocess PAT
Synopsis
- Moving PAT Raman implementation beyond in-line monitoring and glucose control in upstream
- Addressing mounting challenges in downstream
- Raman innovations in single-use, flow cell, and calibration technologies
4:45 pm Roundtable: Benchmarking New PAT Models to Improve Industry Collaboration & Standardization
Synopsis
- Improving the storing and sharing of new PAT models to accelerate progress
- Discussing up and coming models in the PAT space
- Exploring the disconnection between commercial manufacturing and R&D