Day Two - Thursday, November 14
8:00 am Check-In & Light Breakfast
8:50 am Chair’s Opening Remarks
Improving Final Drug Product Quality Through Sourcing & Characterizing Safe & Premium Raw Materials Used in Cell & Gene Therapy Development Process
9:00 am Deep-Dive Workshop: Shining a Spotlight on Key Considerations & Strategic Plans for the Sourcing of Safe & Reliable Raw Materials to Accelerate Production of Cell & Gene Therapies
Synopsis
Many safety considerations need to be thought through when sourcing raw materials, as when, where and how the raw material was made can have a major impact on the final drug product. Understanding the impacts and advantages of the different sources of each raw material is essential for ensuring safe and high-quality materials are bought and used in the drug development process.
Therefore, this workshop will cover:
- Evaluating where is best to source different types of raw materials used in the development of cell and gene therapies
- Understanding the different safety issues concerned with raw materials made using foetal bovine serum and human serums
- Highlighting necessary documentation and characterization data to consider when sourcing a new raw material
- Leveraging internal testing and characterization measures to ensure the raw material is of high enough quality and safe
12:00 pm Lunch Break & Networking
De-Risking Raw Materials Safety & Reliability Through Understanding Key Considerations for High-Risk Human Derived Materials & Single-Use Systems
1:00 pm Human-Derived Raw Materials & Their Associated Risks & Mitigation Strategies
Synopsis
- Review of current guidelines
- Risk assessment and emerging threats considerations for human derived raw materials
- Adventitious agent contaminant risk mitigation strategies
1:30 pm Implementation of Raw Materials & Single-Use Systems in Commercial Manufacturing
Synopsis
- Development vs commercial requirement (RUO vs GMP)
- Raw material risk assessment, fit for purpose testing
- Extractable and leachable considerations
2:00 pm Roundtable Discussion: Achieving Alignment in Single-Use Systems to Improve Sustainability, Manufacturing Controls & Release Testing Approaches
Synopsis
- Streamlining manufacturing controls and testing for single-use systems to ensure alignment between SUT suppliers and drug developers for accelerated developments of safe and effective cell and gene therapies
- Improving sustainability and waste management in single-use systems to reduce environmental impact of single-use containers in cell and gene therapy processes, including compliance with the latest environmental regulations
- Ensuring Annex 1 Compliance of Sterile SUTs and SUT Supplier Audits
2:45 pm Afternoon Networking Break
Establishing Regulatory Compliance by Streamlining Supply Chain & GMP Manufacturing of Your Raw Materials to Develop Scalable Cell & Gene Therapies
3:15 pm Panel Discussion: Delving into the Regulatory Frameworks Governing the Use of Raw & Starting Materials, Including GMPs & Exploring Strategies to Achieve Compliance
Synopsis
- Navigating current regulatory guidance on biological raw materials for ensuring approvals in all regions
- Discussing regulator’s expectation on translating from research to the clinic with proprietary materials to ensure patient safety and clinical approval
- Discussion on areas of future policy for cell and gene therapy raw and starting materials to accelerate development of safe, scalable and cost-effective therapies for patients
4:00 pm Maintaining the CDMO Supply Chain, Ensuring Your Cell & Gene Therapy are Manufactured on Time
Synopsis
- How to maintain your relationship with your CDMO to ensure that materials are delivered on time
- Understanding your CDMO’s supply chain
- How to get your CDMO supply chain to speak with the MST and Manufacturing teams to ensure part swaps and supply chain issues are resolved efficiently
4:30 pm Pharma 4.0 Enabling Next-Generation Manufacturing & Distribution of Raw Materials
Synopsis
- Knowledge graphs for managing the supply chain of raw materials to ensure availability, quality and traceability throughout the development and manufacturing process
- Exploring the benefits continuous real-time batch condition monitoring in regulatory compliance, efficiency and impact to patient
- Multi-echelon digital twins to overcome supply chain challenges specific to gene therapy Manufacturing, such as short shelf lives of critical raw materials
- Scope of generative AI to minimize variability in quality, costs and time