05.20.21 -- GMP - In-house Or Outsource?
Reducing CMC Risk From Moving science from bench to clinic can be done either in-house or at a CDMO. It’s the breadth and width of experience that a CDMO brings to the table that’s critical to success. Are they working with your supplier to really know how to tweak a process to fit into what you’re trying to build?
If you must change critical process parameters later in Phase II, it can change your entire product profile. And that could result in a much higher failure rate. It’s important to focus on making sure you’re optimized early on and ready for scale-up. Here, experts in the cell and gene therapy field share their hard-won experiences.  Reducing CMC Risk
 Strategies For Startups
How To Structure Milestones For Successful Outcomes
ACCESS RESOURCES FOR In-house manufacturing offers the appeal of having complete control over your product and can provide long-term cost benefits. Here, we map out some general considerations and tips for succeeding in GMP manufacturing. When you need manufacturing capacity, how do you decide whether to build or buy? Choose the strategy that best suits your process, product, and team. an online community for biotech startups JOIN BIOTECH MAKERS  Network, share expertise, and get perspectives on common challenges. Collaborate, and connect with your peers. Join Now.
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