NIBRT’s new CSO aims to make Ireland a leader in freeze-dried drugs

29 Nov 2019

NIBRT chief scientific officer Elizabeth Topp. Image: Purdue University

NIBRT’s new CSO, Elizabeth Topp, has big plans for the Irish centre, including bringing 21st century solutions to freeze-dried pharmaceuticals.

As with all good adventure stories, Elizabeth Topp’s began with a dark and stormy night. Just a few months into her role as chief scientific officer (CSO) for the National Institute for Bioprocessing Research and Training (NIBRT), she told that her move from the US came somewhat out of the blue.

“It was cold, dark and snowy in Indianapolis, where I lived, and I got an email about the need for a principal investigator or a scientist position at NIBRT in Dublin,” she said.

“One of the keywords that they mentioned was that they were looking for someone with expertise in lyophilisation; I thought this job description was written for me. I sent my CV and one thing led to another and I ended up here.”

‘NIBRT is working hard to try and anticipate what industry needs are and partner with industry as this new revolution in biologics comes to be’

For those unfamiliar, lyophilisation is one of the most important development processes of pharma drug production. Developed in the 1950s, it freeze-dries a powdered version of a drug that is then reconstituted into a solution before being given to patients.

This may be because the drug is not stable in a solution for long periods. According to Topp, in the US alone, approximately 40pc of approved medications over the last decade are marketed in their lyophilised form.

Ireland savvy to industry’s future

Topp is something of an authority on this process as director of Purdue University’s LyoHub, an industrial consortium to advance lyophilisation technology. First developed to stabilise blood products between hospital wards in the 1950s, lyophilisation still largely takes place in machines reminiscent of giant pressure cookers, called autoclaves. But it doesn’t have to be this way.

“LyoHub is interested in advancing the technology of lyophilisation across the pharma value chain,” she said. “We have instrument manufacturers and equipment manufacturers. We also have end users in pharma, software companies like Siemens and all kinds of folk involved in trying to make the process better.”

While now based at NIBRT, she plans to maintain her connection with Purdue University in Indiana, where she is a professor in its College of Pharmacy, by spending a few months of each year there. By connecting the two through partnerships, she hopes to expand upon NIBRT’s established expertise in the manufacture of the actual drug substance – such as the separation of the protein from cell cultures – and tie in her knowledge and connections of drug manufacturing.

“Something that’s a learning curve for everyone in the industry in Ireland, and globally, is the move into a space that’s increasingly about cell and gene therapies,” Topp said.

“In the US, we had the approval of the first living drug, Kymriah, just a couple of years ago. That’s absolutely a game changer for pharma. I think Ireland is very savvy to the fact that this is the way the industry is moving, and so NIBRT is working hard to try and anticipate what industry needs are and partner with industry as this new revolution in biologics comes to be.”

Looking back on her own career, Topp said she was one of many who admittedly fell into the career she has today.

Having obtained her bachelor’s and master’s degrees in chemical engineering, she started off with an interest in the biological applications of chemical engineering. While this didn’t work out as she had hoped – having made the transition to working on fluid mechanics instead – Topp found herself working as a technician at a neurobiology lab.

‘People have been so welcoming’

Encouraged to look elsewhere by a friend so that she didn’t have to run a “deli slicer for rat brains” for the rest of her life, she got the chance to do a PhD in pharmaceutics at the University of Michigan – a topic that she admittedly knew nothing about at the time.

“I wanted to have some kind of biological or medical application of my engineering and STEM interests and [the PhD] turned out to be the thing that worked,” she said.

While not long in the new role, Topp has already started the process of bolstering the drug manufacturing side of NIBRT with a new analytical method to speed up and improve stability studies for how proteins perform in lyophilised solids.

Currently, these stability studies take a long time to complete. “If we can predict which formulations or processes are most likely to produce a stable product, then we can cut years off development time,” she said.

This is just one of the efforts currently underway at NIBRT at the moment, and now Topp’s happy to call Ireland a new home.

“I’m really absolutely enjoying [the new role] and settling in well,” she said. “People have been so welcoming and open which has been just delightful; not only here at NIBRT, but people in Ireland as well. It’s been a tremendous welcome.”

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Colm Gorey was a senior journalist with Silicon Republic