Reducing Costs and Increasing Accessibility of ADCs & Cell and Gene Therapies

Antibody drug conjugates and cell and gene therapies offer significant therapeutic promise, but their production costs can be sky high. Beyond AI and ML, what other digital tools or innovative manufacturing strategies do you see holding the most promise for reducing costs and increasing accessibility of these treatments?

I think the reason in both of the cases of those modalities that costs are high is because capacity is constrained. So, antibody drug conjugates need very specialized manufacturing capacity and skills of people working in those facilities to get the product out the door. Actually, you don't need a lot of an antibody drug conjugate to treat a lot of patients because the drugs are extremely potent. But you needed to do a multi-step manufacturing process, each of each of those steps is very specialized, and has subject to variability.

So, you have to make a biologic, you have to make a peptide, you have to make a small molecule, and then you have to link these three pieces together. And you have to do that to make sure you protect the drug from the worker, because the drug has to be sterile. And on workers in factories, you know that you have to have, you know, extremely stringent cleanroom work situation. And you also have to protect the worker from the drug because the drug is highly potent and can be toxic elements of the drug are toxic. So, you need to the industry, I think needs to effectively invest in more of this specialized capacity to get the economies of scale in production of antibody drug conjugates.

They also need to invest in training more people who can work in those very specialized manufacturing environments, where they're, as I said, protecting the drug from the draw from themselves and on the other bacteria that they might bring into a cleanroom environment, but also making sure that they're keeping themselves safe and not exposing themselves to a drug. So, we believe there's a lot of potential to invest in improving manufacturing processes, improving training of workers, helping workers execute these tasks, building more facilities quicker getting those facilities validated and up to production faster. And all of that will improve the capacity for making antibody drug conjugates and should help bring down the manufacturing costs. The other modality you mentioned, Miranda is the cell and gene therapy. Again, there's a capacity issue. Every product, every batch is made from any of those products is made for single patient. And so, you have to take the patient sample, bring it to a factory, have people work in that individual sample and then ship it back to the individual patient. And the shipping costs the high labor content per batch per patient. That all creates a huge ramp up in in cost of goods sold.

And so, I think what you're going to see increasingly is greater use of robotics and bringing the production of the cell and gene therapy closer to the patient into the hospital into the specialized care centers, where you don't have the logistics and transportation costs of shipping the product around the world. And you can process more samples more quickly with less people and more robotics. I mean, a good example of that is specialized diagnostics were done in the past, sometimes a specialized diagnostic test, the sample had to be shipped off to a separate location and wait for the results to come back. Now, most big hospitals have robotic lab testing equipment, where the sample can be tested very quickly, with minimal human intervention, and at relatively low cost. So, I think hopefully, we will see the same thing happening in the cell and gene therapy space that we've seen in the in vitro diagnostic space in the coming in the coming decades and years.