Establishing scalable technology platforms that allow for varying levels of production throughout the different stages of clinical testing can minimize process development timelines, drug-comparability risks, and - ultimately - costs.
Regenerative therapies based on living cellular products will change the way medicine is practiced and will revolutionize healthcare over the next 10 to 20 years. However, developing commercial products within the context of pharmaceutical regulations is a challenge. Many hurdles can be tackled systematically by understanding future manufacturing requirements and creating focused research-and-development programs. The ultimate goal is to develop …

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