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Business & Regulation Business Practice, Standards & Regulation, Trends & Forecasts

Leading the Way

What drew you to biopharma manufacturing?

I wasn’t actually the kind of person who was fascinated by science or the idea of making medicine at a young age. My first job was as a process engineer – but in a large fertilizer complex start-up in Cork, Ireland. It had a huge number of complex processes and equipment – as a fresh graduate engineer I felt like I was in Legoland! After that, I joined a Cork-based European pharma company, which was focused on extracting active ingredients from the ginkgo biloba tree. It became clear to me that I wanted to be involved in starting up and operating large, complex pharma sites.

How did you end up at NIBRT?

It has been a long journey. Along the way, I started up two biopharma production sites for US multinationals, acting as site general manager in both cases. One site was for Mallinckrodt Medical in the 1990s, in Dublin, focused on small-molecule synthesis. The second was a Genzyme biologics operation in Waterford, Ireland, in the early 2000s. I learned that I had a real interest in building successful teams and in 2008, I became Senior Vice President Manufacturing, with responsibility for a number of Genzyme manufacturing sites in Europe and the US.

But in 2014 – after decades in the industry – I decided it was time to do something different, so I set up my own consultancy company. Soon afterwards, I received a phone call about the NIBRT role and was immediately enthused. I’d already spent two years as the chairman of Biopharmachem Ireland, and many more years as a Council member. I understood the needs of industry, both from a training perspective and from a manufacturing and research perspective – the two core tenets of NIBRT. I felt the role was ideally suited to me, and I was delighted when I got the job!

What changes have you seen in the industry over your career?

The big change is the advent of biologics – monoclonal antibody products are well-established, and gene therapy products are on the way. Nevertheless, biologics manufacturing is relatively immature compared with small molecules and there is much we can do to improve bioprocessing. On the small-molecule side, we’ve seen efficiency improvements from lean techniques and the greater use of automation, although this still lags behind other industries, such as oil and gas.

The dramatic increase in regulatory requirements and inspection visits is another high impact change – large production sites may have multiple day inspections every second week, which is extraordinarily onerous. One reason for this is that, twenty years ago, emerging economy regulatory agencies carried out truncated inspections, but now they are as in-depth as an FDA or EMA inspection. Mutual recognition of inspections is long overdue!

I’ve also noticed that job roles have become much more specialized and, because of the complexity of the industry, this is leading to a silo mentality. I think that we had better collaboration a few decades ago when there were more generalists.

What are your biggest achievements at NIBRT?

When I took over as CEO around 18 months ago, NIBRT was already well on the way to the success it currently enjoys, but I hope I’ve helped coalesce the team around our key priorities, and thereby contributed to our recent growth rate (of more than 20 percent). One key success has been the industry demand for our training courses – we had over 4,000 trainees in 2016, many of whom were international. We’ve also set up successful collaborations with partners such as Bristol Myers Squibb, GE Healthcare and Thermo Fisher Scientific, covering not only training but also manufacturing research. And we’ve significantly developed a biologics product characterization-focused contract research business based on the bioanalytical expertise of NIBRT’s Pauline Rudd and Jonathan Bones.

Why are you so passionate about biopharma training?

There’s already a huge demand for trained personnel to meet the industry’s current global growth – and this will only increase in the future. This industry is changing rapidly and we need to keep pace by fostering an industry culture of lifelong skills acquisition. Many companies claim to recognize this concept, but we need more to actively support it. Nobody can cram all of the skills and training required for biopharma manufacturing into an undergraduate or a postgraduate degree – the field is far too complex.

Our pilot plant allows trainees to gain hands-on experience with upstream, downstream and finishing technologies without putting product or operations at risk. Back when I was at Genzyme, we had to process batches that were worth €25 million each, which puts tremendous pressure on the operators, who would be almost frozen into inactivity at the thought of the cost of a single mistake! NIBRT helps prevent that situation by allowing operators to build their confidence before doing the real thing.

As we move into 2017, where do you think the industry’s priorities should lie?

The cost of biologics must be reduced to improve patient access. Part of the answer is to reduce manufacturing costs; for example, by adopting continuous manufacturing and single-use technology. Some companies, however, are fearful of changing their legacy processes. Change will require greater collaboration between equipment vendors, manufacturing companies and – very importantly – regulators.

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About the Author
Dominic Carolan

Dominic Carolan is CEO, National Institute for Bioprocessing Research and Training (NIBRT), Dublin, Ireland.

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