SHINE employee Mindy Becker takes you on a virtual tour of our production process, showing how this "smart bomb" for cancer treatments goes from raw materials to life-saving therapies.
We're going to go enter SHINE’s lutetium manufacturing facility, which is actually the largest lutetium manufacturing facility in North America and it's right here in Janesville, Wisconsin. The start of our process is driven out of this room. One of the biggest differentiators for us as a company is that we create our own ytterbium supply. One of the main suppliers of ytterbium in the world is out of Russia.
A lot of manufacturers of lutetium are single source. We actually have the technology in-house to create our own ytterbium supply. We are walking into our production side of our lutetium chloride manufacturing facility. This is going to be how our operators come in and get ready for their day. We do operate in a clean facility, so when an operator comes in, they're going to grab a pair of scrubs, grab their dedicated shoes, and then walk over and to our clean side of our room.
And then in this room, we are going to put on the rest of our PPE, and then they're ready to go and start their day. The first step to our manufacturing process is actually our solution prep. So we have our chemical preparations room here in this room. Our operators are going to prep all of the solutions that are needed for our production.
This is also a clean environment. We produce an active pharmaceutical ingredient. And then after this we will load up all of our solutions onto a tray and take it down to our production room. When the operators come through they're actually gowning up for an anti-contamination perspective. So we are going into a radiological area where there is potential for radiological contamination.
Once they're all gowned up and ready to go through we will go right into our production room. So this is our main production room. What makes up our entire process line are three separate hot cells. In each of the hot cells, there are different compartments, and the production flow goes from left to right.
In our first hot cell, we're going to be bringing in our radioactive target. It's going to come in from the back side. We're going to pull it up into the cell, open it up, and then transfer over our product and put it into our bulk separation process. And then after that, everything's going to be dissolved and then go through a high-performance liquid chromatography process as we go from our first hot cell into our second hot cell, we are dissolving what's left of our solid material.
We now have our purified lutetium, and then we reconstitute to a specific activity concentration for the customer. And then we will actually go through our full dispense process. So we use a semi-automated dispensing process with a autoclave for end sterility of our final product. This is our main quality control lab. So after everything's filed and ready to ship out before we can ship it out, you need to verify that it meets all of our final product specifications.
So we submit a small sample of our final product to our QC lab and they do all final release testing in here. So they're looking to make sure that it's purified and you don't have any ytterbium left over. We're verifying that there are no metals left in our final product and that it is ready for use in our patients.
We really combined forces from the SHINE Therapeutics team and the SHINE systems and manufacturing team to bring this facility online. We're talking about one year from concept of what this facility needs to do. And one year later we're about to run production in this facility. So that took six months of engineering time and then you have to purchase all of your equipment, do the installation and testing of it.
It was an incredible feat to make something this scale.
