In this podcast, we spoke with Dr. Brad Taylor from Nucleus Biologics and Randy Jacinto from Cytiva about the benefits of using a custom media for cell and gene therapy process development. Topics included current development challenges, increases in the number of cell and gene therapies in clinical trials, and employing custom cell culture media solutions to address these issues. We started the discussion by talking about the most pressing challenges facing cell and gene therapy development. Randy began by explaining that the most pressing challenges are the cost of manufacturing, lower than expected adoption rates, and complex logistics around supply chain. At Cytiva, he shared that they are addressing these challenges by automating many parts of the workflow and simplifying the logistics. In addition, the recent partnership with Nucleus Biologics will allow customers easy access to cell culture media solutions that can help accelerate the development of these cell therapies. Brad added that he also hears from customers that there is difficulty accessing consistent, reliable products and materials in single source situations. Companies are working with suppliers who guard their materials with trade secrets and this hinders the ability for that therapy to progress to the clinic. He went on to say that the scalability of cell therapies is also an issue, particularly as the industry moves into allogeneic therapies where manufacturing requires larger scale processes. He stressed that at Nucleus and in conjunction with Cytiva, they are committed to making sure that customers have a consistent supply of reagents and cell culture media to help them meet the rigorous quality standards. Next, I asked about what potential issues will arise with the large increase in cell and gene therapies in clinical trials, and the forecasted further increase over the next five years. Brad said that the regulatory approvals of cell therapies is really accelerating globally. Scaling processes for allogeneic therapies certainly lends itself to custom development and custom process development. So, it is important to not be locked into one size fits all type models. Nucleus wants to make sure that developers of these complex therapies can derisk their processes. Developers want to be able to accentuate desired attributes of their cell therapies and reduce those that are not desirable and cell culture media can have a profound impact in this area. He went on to describe a collaboration with the University of Pennsylvania, where Nucleus demonstrated that individual components can help expedite therapies and improve outcomes. In those publications, authors were able to show an increase in in vivo efficacy, cytotoxicity, and transduction efficiency by changing the cell culture media components for CAR T cells. Randy added that in addition to the scalability challenges, another primary challenge around cell therapies is the labor cost. Cytiva has estimated that labor costs contribute close to 48% of the total manufacturing costs of the drug therapy. To address these labor costs, Cytiva is working through automation as well as digitalization of the workflow and this will help overall improve the scalability and reduce costs. In addition, Cytiva is working with Nucleus Biologics because they truly believe that custom media is a key component in improving the overall efficacy of that drug therapy. Next, I asked about the focus of the Cytiva and Nucleus Biologics collaboration agreement and what they hoped to achieve together. Randy explained that it could not be a better partnership because the companies share a common vision of advancing novel therapeutics like cell therapies, which they believe will have a true transformative impact on the healthcare landscape. He went on to say that the challenge has been with science workflows advancing m...