- Design Flexibility: Key elements to incorporate into facility design to add manufacturing flexibility in the future, especially for CMOs
- C&Q Strategy Development: Following a risk-based approach is key to delivering a compliant package within tight time constraints. How can you tailor the C&Q to be flexible and fit the needs of multiple clients and/or processes?
- Scheduling Do’s and Don’ts: How to avoid project delays and how to accelerate certain phases
Cell and Gene Therapy production is one of fastest growing areas in biotechnology. There is increased demand to bring manufacturing spaces online quickly and with enough flexibility to accommodate process changes, especially for contract manufacturers. While this is becoming easier to accomplish through single-use technology and plug-and-play vendor packages, there are certainly pitfalls to navigate to ensure projects are delivered on-time and within budget.
By paying special attention to these 3 items, projects can be delivered more quickly and in a compliant fashion, greatly reducing business risk and ultimately leading to a more profitable operation. Topics of discussion will stem from both direct project experience and industry guidance from organizations such as ISPE. The use of a risk-based approach will be highlighted, as this is one of the most key elements to reducing cost and adhering to schedule. While this oftentimes means early involvement from various groups, establishing risks to the product/process early in the project lifecycle reduce costly design changes and allow for a compliant, hyper-focused C&Q plan which can meet tight schedule constraints. More attention to this at the beginning of a project ultimately saves time at the end when adherence to schedule is much more critical.
Cell and Gene Therapy projects are especially challenging. The cutting-edge nature oftentimes makes for tight timelines, but also requires a lot of flexibility considering how rapidly technology is changing. This impacts all areas of the project lifecycle, and this webinar will discuss some of the areas where key improvements can be made to save time and money.
For more information or to register for this event, visit Cell and Gene Therapy: Taking a New Facility from Construction to Production.
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Mira Nabulsi, Xtalks, http://www.xtalks.com, +1 (416) 977-6555 x 400, [email protected]