Setting the Stage for Successful Clinical Manufacturing of Cell and Gene Therapies
Tales from the trenches: lessons from industry leaders on how to ensure quality, improve patient access, and reduce the cost of manufacturing.
Are you preparing to advance your therapy into the clinic? Discover how to avoid common pitfalls therapy developers make when manufacturing cell and gene therapies.
In the race to get novel therapies into clinical trials, early-stage biotechs must objectively assess their readiness and make critical decisions about where and how to manufacture.
Join us as a panel of industry experts shed light on where most early stage biotechs go wrong in overestimating their readiness. Encouraging you to take an in-depth look at your product, capabilities, technologies, processes, and team, this panel discussion will prepare you for success as you bring your product from the bench to patients worldwide. You’ll gain coveted insight needed to advance your readiness as you learn what key indicators to look for and how to assess them.
Immediately applicable, these tales from the trenches are guaranteed to save you time and money by revealing what you don’t know until you’ve been through every step of clinical manufacturing.
WHAT TO EXPECT
Part 1: The panel addresses key challenges associated with clinical manufacturing and the common mistakes therapy developers make when faced with external pressures. Topics covered include:
- A well-defined product: why it’s so important to define specifications, dosing, QBD, CPP, and more early on
- Assessing scalability, repeatability, and GMP readiness of your manufacturing process
- Minimizing the chance of error, reducing contamination risk, and speeding up processing time
- The criticality of having the right team built prior to manufacturing
- Is outsourcing to a CDMO the right move, and are you ready for that partnership?
Part 2: The panel answers audience questions with an interactive Q&A.
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