Easter and GMPs

I think of peanut butter chocolate eggs, Peeps®, and Bunnies at Easter, but what does that have to do with GMPs? Let’s pick my favorite, dark chocolate homemade peanut butter eggs. When I think of peanut butter eggs, I think of processing. I’m a biochemical engineer by training, and we think a lot about processes. Peanut butter and chocolate are both from naturally occurring starting materials, and have some inherent variability since not all peanuts or chocolate beans are the same. Manufacturers try to keep them consistent, but I’m sure there are some variances. This is the same for biologics—they all have inherent variability. This can be a challenge when producing any biologic. For example, I have seen some cell/gene therapies that have a low (perhaps 60 percent or so during development) batch success rate. This is often because the process is complex, may not be fully developed/optimized yet, and there are variabilities that are difficult to control. When GMPs are applied, then we have to control and ultimately validate this process, and it gets even more challenging. It can be helpful to control key process parameters in a given range first, then work on optimization. For process validation, it may be necessary to take data from many batches, not just the typical three batches. For in-process testing and end-testing during development, it may be helpful to have wider ranges for specifications at first, then refine and narrow them in development, prior to licensure. For the process itself, there may be ways to optimize the process and control critical materials, to remove some of the variation. Thus making biologics with consistent quality attributes continues to be a challenge, just like making anything from natural materials. Happy Easter, and I hope the Easter Bunny brings you some chocolate eggs!