Building Phase-Appropriate Quality from Preclinical to Commercial with Jackie Klecker

Hello, everyone. Welcome to the Life Science Rundown, the podcast where we discuss current, regulatory complexities facing life science industry and explore innovative ways to overcome those challenges. I am your host, Nicholas Catman, president and CEO of the FDA Group. Before we get started, here is a quick word about who we are. The FDA Group is a consulting firm that helps life science companies in the areas of regulatory submissions, audit projects, log inspection, staff augmentation, and remediation. So if you ever find yourself a need, just head over to the fdagroup.com to check us out and get in touch. So today, I am speaking with Jackie Clicker. Hey, Jackie. How are you? Hi, Nicholas. Fine. How are you? Doing excellent. Thank you so much for joining me today. I'm really excited to get into today's discussion. Before we before we touch on the, the topic, would you kindly introduce yourself? I will. Thank you. I'm Jackie Clecker. I'm the executive vice president and head of quality and head of development services here at Lifecore Biomedical. Lifecore has been around sixty years now, and we are a fully integrated CDMO. We do really specialty formulation, aseptic filling into vials, syringes, cartridges. We also do med device and pharmaceutical drug products along with some biologics. We have about 20 commercial SKUs, FDA, and Europe right now. That's our CDMO side, and we also produce a sodium hyaluronate API, which is our product and used throughout the world. Okay. Awesome. Thank you so much. So we will be talking about how scaling from preclinical to clinical and then to the commercial, it can be a daunting task. And we wanna understand how can sponsors ensure that they're asking the right questions to build robust processes while incorporating phase appropriate approaches, especially when getting it right saves time, resources, and money. So, to start, like I mentioned, you know, scaling that product from preclinical to commercial, it can really seem like a monumental task. From your experience, what are, what are the most common missteps companies make during this transition? It's a good question. What I've seen is some of the the sponsors would come in with their preclinical solutions and they would be requesting us to validate analytical methods fully, for example. That's very expensive endeavor and not necessarily needed at preclinical as the sponsor continues to understand their product. So that's an example of the sponsor asking for too much information. I've also seen the other side of it where the sponsor will come in and really doesn't understand the design space of the solution they're providing to us. So it it's they haven't really done the design testing. There isn't the understanding of what are the material variability attributes or even, you know, if there's a specification for pH, is is that the right spec? Should it be different? Will it be more stable if it's different? So those type of things. And and we're looking at it …