Lexington drug manufacturer undergoing $25 million expansion at Coldstream

Podcast

Lonny White is chief operations officer at Piramal Pharma Solutions Inc.-Lexington, formerly known as Coldstream Laboratories. The company, part of an international conglomerate, provides sterile drug product development and manufacturing services.

Click here to hear the audio version of the interview: http://www.kentucky.com/news/business/article45076461.html

Q: What goes on at Piramal’s Lexington location?

A: We’re a manufacturer of sterile drug products and what we manufacturer in Lexington primarily are oncology drugs, better known as cancer treatment agents. The Lexington site is a unique organization inside of the Piramal organization in that we are the team that makes sterile drug manufacturing. It’s not like an oral solid dosage like a Tylenol. It is injected.

Q: And how many people employed?

A: Currently, we have 140 full-time employees. We’re actually growing that number to around 170-175 by March of 2017.

Q: I understand that there is military in your background?

A: Yes. I spent 8 years in the U.S. Army. And in my tenure in the military, I worked in both blood centers and in a hospital setting. So, I have a unique perspective on the drug product we make at Piramal because I was a laboratory technician and as the recipients of these drugs came into the hospitals, I saw their faces. I drew their blood. I had conversations with them. I worked directly with them. I’ve seen what the disease did to their families, to their relationships. So, I got to have that opportunity to really look people in the eyes and see what we’re doing as a healthcare industry and organization.

Q: And how have you brought that experience into what you do now?

A: I was responsible for all of the quality at Piramal Healthcare when it was Coldstream Laboratories. Now, I’m the chief operating officer. So, in my quality units, I tell them about my experiences, about the patients, try to get them to understand that what they do, every valve that they touch, every product that they run through that line, that is a person. And so, it’s about more direct communication with individuals. Let them know. Let them understand. Talk to them about their family members who have had cancer and its devastating effects on a life, to relationships, and to homes. It’s very easy on any manufacturing line to become callous to what you’re doing and the end product of that. So, it’s really about trying to gain an understanding within the organization of that end user.

Q: Piramal is in some 30 countries around the world. Why Lexington?

A: Piramal does a lot of solid oral dosage forms throughout the world. But they really wanted to gain a foothold into the sterile drug marketplace. They looked a little over 2  1/2 years for sterile drug manufacturers. When they came to Lexington and saw the talent pool and the technology that the university had purchased when they were building this, that’s what attracted them. We have isolator technology. It’s the leading technology in the industry to manufacture sterile drugs. And so, they talked with our leadership team and made the decision that the Lexington site was the site they wanted to buy.

Q: Can you tell us a little bit about some of the products that are being manufactured at Coldstream?

A: We have confidentiality agreements with our partners so, I can’t disclose the product name or the companies. But most of what we do at the Lexington site is for different types of targeted cancers. There’s a new technology in the medical industry called the antibody drug conjugate. They’ve taken older drugs, cancer drugs, that have been on the marketplace and have come off of patent and redesigned these drugs into antibody drug conjugates. It’s more targeted to the cancer cells or to those tumors. And so, it takes a product that was, let’s just say 50 percent effective in fighting the cancer, but also wreaked havoc on your body, and redesigned that to make an antibody drug conjugate that targets that particular tumor. There’s a lot of work in the pharmaceutical industry on honing the technology and these products to be more specialized and target those tumors. It takes a drug from say 50 percent effective to 80-90 percent effective and it’s less damning on your body and your health.

Q: I’ve read in the company’s literature that one disease that Piramal is focusing on is known as Batten disease. Tell us about that.

A: Batten disease impacts young kids’ brains. If your child is diagnosed with Batten disease, it’s typically not a matter of if they pass away. It’s a matter of when. At the onset of this, kids will be around 3, 4, or 5 years old. And it’s very heart-wrenching. As a parent, you have to watch your child slowly decline in their motor skills, in their ability to interact. It’s such a small population of people that a lot of companies will not pick up that drug because it’s not terribly lucrative. And so, the company that we’ve engaged with has developed this drug for Batten disease. They’ve injected this into these kids’ brains and they’ve seen remarkable — I mean, absolutely astonishing results in that it’s not only stopping the effects of the disease, it’s reversing some of those effects. We’ve been manufacturing this product for a couple years now in clinical trials. We’ve gotten our first inspection from the Food and Drug Administration.

Q: What motivated Piramal to take on something that seems less-than-profitable?

A: The owner of the product is a different company. They brought it to us to manufacture. The primary business platform the university designed the Coldstream site was for niche or smaller-scale products. A lot of large pharmaceutical companies are just not going to be troubled with smaller manufacturing campaigns because they’re not lucrative enough. That’s a market that we really need to tend to as a pharmaceutical industry because it’s meaningful in people’s lives. And even though it’s not large-scale manufacturing, it’s a very, very important product. The difference with Piramal is we’re going to continue with the smaller-scale manufacturing. Plus, we’re going to do larger-scale manufacturing. So, we’ll serve two purposes as an organization.

Q: Recently you announced a significant expansion at Coldstream. About $25 million. When will that begin and what will be the result of it?

A: When the Piramal organization purchased Coldstream Laboratories, the executive leadership team had a vision of what the site could be and what the investment capital would be. After we met with the Piramal organization we walked away from that interview with them as a potential buyer, seeing them as the most sophisticated organization coming in to look at us and as an organization that had a vision for growth, as well. And so, when the transaction occurred, we began to talk about what type of equipment, what type of technology, what type of talent would we need to bring in to Lexington to grow this site. We’re in phase one: redesigning the current infrastructure, purchasing equipment to go in the current footprint. A little over $11 million of that is already spent. We’ve done quite a bit of work and we’ve already seen dividends on the work at this site here in Lexington.

This story was originally published October 30, 2016 at 10:42 AM with the headline "Lexington drug manufacturer undergoing $25 million expansion at Coldstream."