Panel Discussion: Emerging Technology to Maturing Capability, Where is Continuous in the Technology Adoption Life Cycle?
Time: 8:15 am
day: Day One AM
Details:
• As the ETT sees its first graduation with Continuous Direct Compression (CDC) technology, we reassess where continuous manufacturing stands on the technology adoption cycle. Is this still a technology for innovators and early adopters, or are we making the steady move towards the early majority?
• How does this differ between small molecules, traditional mAbs and newer modalities?
• Top-down or bottom-up: which approaches for continuous processing adoption has produced the most impactful results in pharma?
• Quicker Speed to Approval, Speed to Market and Improved Product Quality – Too Good to Be True or a Reality Ready to be Adopted? A recent audit by the FDA shows applications that used continuous manufacturing were approved in a shorter time than the comparator batch applications, and the products using continuous manufacturing entered the market twelve months faster on average after regulatory submission, and three months faster after approval when compared to the batch applications. Is this due to increased communication with emerging technology team (ETT) prior to submission or genuine faster approval?
