Good manufacturing practice

Typically, if you're thinking about GMP-grade plasma, you could be waiting anywhere from six to nine months for that batch of DNA.

And we promise to deliver that in less than 12 weeks.

People are starting to recognize that synthetic DNA is going to disrupt.

So, for example, if I wanted to make an mRNA therapy, but you wanted to make a viral vector therapy, the DNA that we would provide would confer benefits for that application.

Is the process... quicker

yes much quicker much quicker I think typically if you're thinking about GMP grade plasmids for clinical application you could be waiting anywhere from six to nine months for that batch of DNA and we promise to deliver that in less than 12 weeks so really for some application areas that that's of utmost importance and particularly in personalized cancer vaccines you will have heard about the success of the the Moderna and Merck vaccine in their late late phase three there and We can do that in, you know, a couple of weeks.

And that's really a product offering we have niche to that market.

It's sort of like, why is nobody else in 50 years thought of or tried to? I know you can't give away your secrets.

You know, that gives them that clear indication to the market, it's not yet ready.

Well, I was going to say it's also a sure sign to the manufacturer that their investment in CGMP-compliant API is likely to pay off.

I mean, we talk about research-grade product.

Research-grade product is not authorized for use in human drugs.

We just got at TPP.

We just got our CGMP again.

They came by and did an audit.

Everything was clear.

It's really good at language.

But when you are talking about GMP, good manufacturing processes, about manufacturing drugs for patients, you need not probabilistic technology like LLM, but you need deterministic technologies like machine learning.

And machine learning has been around for decades now.

It's being already used by the pioneers in the manufacturing processes.

That's how we have been working with our suppliers over the years.

Yeah, and I would like to add, being in this industry for almost 30 years and seeing the industry evolve over the last couple of decades especially, and with the FDA GMPs being enforced or implemented probably now almost 15 years ago.

So yes, there's been an evolution.

As time goes, the requirements are getting more and more stringent.

When we move to clinical trials, we have to be certain that the patients receive a product whose quality is known and controlled.

And then GCPs, and by the way, let me back up and say, we do not have the capabilities at UAMS to do GMP manufacturing or synthesizing.

So again, an outside, a manufacturer, CMO, Contract Manufacturing Organization, will be engaged to help with the manufacturing.

And in that IND packet, the Investigative New Drug Application that you ultimately will be applying to FDA to give you approval to move into clinical trials, there will be a whole section on CMC, Chemistry, Manufacturing, and Controls.

all revolving around manufacturing the product under GMP.

And you have to prove to FDA that you generated your product in a reproducible manner.

GCPs, or good clinical practices, we can do here at UAMS, and we do very well.