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Monday, September 23, 2024 - Pre-Conference Workshops - EST/EDT (Eastern Daylight, GMT-4)
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Monday, September 23, 2024 - Pre-Conference Workshops - EST/EDT (Eastern Daylight, GMT-4)
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Beyond mAbs: Manufacturing the Next Generation of Therapeutics
9:00am - 9:30am
Lessons Learned from the Manufacturing of Traditional Antibody Drug Conjugates
- Ensuring the quality and consistency of the end product
- Conjugation challenges associated with drug design
- Effective collaboration with CMOs in Preparation for commercialization of ADCs
9:30am - 10:00am
Overcoming Manufacturing Challenges Associated with Non-Traditional ADCs
- Process design and implementation for bi- and multi-specfic ADCs
- Elucidating the drug to antibody ratio (DAR) of your product
- Analytical considerations for the characterisation of complex biologics
10:00am - 10:30am
Scientific Track Presentation
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Beyond mAbs: Manufacturing the Next Generation of Therapeutics
11:00am - 11:30am
CMC Considerations for the Manufacturing of Radiopharmaceuticals
- Case study
- Working with components with short half life's
- Sourcing and ensuring traceability for radioactive supply
11:30am - 12:00pm
Unleashing the Power of T-cell Engagers: Building Robust Manufacturing Processes
- Exploring the unique challenges of T-cell engager manufacturing compared to traditional biologics
- Pre-emptive design and optimization of robust production processes
- Case study example
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Beyond mAbs: Manufacturing the Next Generation of Therapeutics
1:00pm - 1:30pm
Manufacturing and Scale-up Considerations for the Development and Commercialization of Complex Biologics
- Ensuring effective CMC, analytical development, and quality monitoring for the production of safe and consistent therapeutics in line with regulatory advice
- Anticipating potential bottlenecks and addressing these to ensure smooth scalability.
- Working with partners to assist in the manufacturing of next generation therapeutics.
1:30pm - 2:00pm
Fortifying the Supply Chain: Building Resilience for Complex Therapies
- Preparing a secure and reliable network of suppliers by analysing the vulnerabilities of complex bioprocessing supply chains
- Best practices for successful collaboration and transparency with stakeholders/vendors
- Strategies to mitigate risk and ensure reliability.
2:00pm - 2:30pm
Scientific Track Presentation
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Beyond mAbs: Manufacturing the Next Generation of Therapeutics
3:00pm - 3:30pm
How AI Can Streamline Manufacturing and Avoid Roadblocks for your Next Gen Therapeutics
- Utilizing AI-aided design to anticipate potential manufacturing challenges
- Implementing AI into pre-existing bioprocessing workflows
- Case study examples
3:30pm - 4:00pm
Generative AI for Optimization of Biologics Design, Development, and Manufacturing
- Applications of generative AI within bioprocessing and next-gen therapeutics manufacturing
- Optimization of process parameters and product design for efficient production
- Ethical considerations and responsible development of AI in biomanufacturing – what to keep in mind.
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