This webinar provides practical guidance for professionals involved in cell therapy manufacturing, focusing on common challenges faced during clinical development and the transition to commercial production. The session is designed for those responsible for bringing cell therapy products to market, including manufacturing leaders, project managers, and quality professionals.
What you'll learn
Key Pitfalls in Cell Therapy Manufacturing: The session outlines five critical missteps that can disrupt the path from clinical development to commercialization, including misaligned partnerships and underestimating supply chain complexity.
Strategies for Sustainable Scale-Up: Practical approaches are discussed for building robust, scalable processes, with an emphasis on early commercial planning and the importance of automation and digitalization.
Selecting the Right CDMO Partner: Guidance is provided on evaluating contract development and manufacturing organizations (CDMOs) for stability, experience, and alignment with long-term goals.
Managing Cost and Value: The webinar addresses how to balance cost pressures with the need for quality and reliability, cautioning against choosing partners based solely on the lowest price.
Case Study Insights: Real-world examples, such as the Lonza and Bluebird Bio partnership, illustrate how to navigate challenges and achieve successful commercialization.
Who should watch
- Cell and gene therapy developers preparing for clinical or commercial manufacturing
- Manufacturing and operations leaders seeking to improve process reliability and scalability
- Quality and regulatory professionals involved in CMC planning
- Project managers evaluating CDMO partnerships
Some key questions we answer in the webinar
Q: What are the most common pitfalls in cell therapy manufacturing that can disrupt progress from clinical development to commercialization?
The webinar identifies five key pitfalls:
- Misalignment with the CDMO partner, leading to instability and delays
- Underestimating the complexity of supply chain logistics, especially for autologous therapies
- Failing to adopt a commercial mindset early in the product lifecycle
- Choosing partners based solely on the lowest upfront price, which can result in higher long-term costs
- Overlooking long-term scalability and readiness, risking future supply and automation challenges
Q: Why is early commercial planning important in cell therapy manufacturing?
Early commercial planning is essential because the requirements for quality, scalability, and regulatory compliance increase significantly as products move from clinical to commercial phases. Without early planning, companies risk bottlenecks, inspection findings, and launch delays. Building commercial-ready systems and processes during late-stage development helps ensure a smoother transition to market.
Q: How should companies evaluate and select a CDMO partner for cell therapy manufacturing?
Companies should look for CDMO partners with proven stability, experience in the relevant modality, and a track record of taking products from clinical development to commercial launch. Alignment in vision and strategy is critical, as is the partner’s ability to manage complex logistics, invest in automation, and provide transparent, experience-backed pricing models
Q: How can companies balance cost pressures with the need for quality and reliability in manufacturing partnerships?
While cost is a significant factor, the webinar cautions against choosing partners solely based on the lowest price. Instead, companies should assess the value a partner brings in terms of experience, reliability, and ability to support long-term growth. Transparent communication about needs, capabilities, and expectations helps ensure that both parties are aligned and that the partnership delivers sustainable value.
Q: What role does automation and digitalization play in scaling cell therapy manufacturing?
Automation and digitalization are crucial for managing the complexity and variability of cell therapy manufacturing at scale. They help streamline processes, reduce manual errors, and ensure traceability from patient to product and back. Investing in digital systems for supply chain orchestration and manufacturing execution enables efficient, reliable, and scalable operations.
Watch the Webinar
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