Bringing the Outside In – When a Pharma Factory is Needed in the Future Part 3

This article was originally published in the March April issue of Pharmaceutical Engineering® magazine. Catch up on this series by reading:

"When a factory is needed in the future, what could it look like, and how should we think and work differently to build it?"
Roger Connor
Roger Connor
President Global Manufacturing Supply

Let’s shift gears and talk about gene therapy and its impact on pharmaceutical manufacturing.

It’s going to be totally game-changing. Remember GSK launched the first approved cell and gene therapy, Strimvelis, in Europe. This is a seriously impactful cell and gene therapy that we’ve brought to market. It is totally different from anything we have made before. So while the clinical trial supply chain and commercial supply chain are different for a normal pharmaceutical product, for cell and gene therapy they are exactly the same.

These products can have an incredibly short shelf life. That means your manufacturing facility has to be co-located with your treatment facility, or at least be very close. Your laboratory also becomes your factory. For GSK, that has meant forging some strong external partnerships.

Can you talk about creating the right conditions for developing cell and gene therapy?

Absolutely. We’re a big presence in the UK, and we have been talking to the government about what will make the UK the go-to location for cell and gene therapy development and manufacturing. There are a number of critical factors: links to academia, to encourage research; the availability of specialist skills and labor; and a favorable fiscal environment to attract investment. Put these things together and you will attract cell and gene therapy companies.

With Brexit looming, that last point might prove difficult.

To be honest, at GSK we don’t see Brexit as driving our choice of location for manufacturing. By far the most important factor is access to the skills and capabilities we need. There are going to be challenges with Brexit, such as the importation of product and retesting. We’ll have to direct some resources to address that.

Looking to the future, from a manufacturing perspective, what are the top three obstacles the industry faces?

As an industry, we are risk averse. We need to take some chances on new technologies and really swing behind them, put our best brains on them, and make them work. There’ll be bumps along the road, so we need to be courageous and place some bets on big technology. That’s one.

Two, in our industry we tend to work in silos. We have to work in partnership more with R&D and commercial teams, sharing business goals. It’s not enough to speak from a manufacturing perspective only. We need to work together to deliver a strategy and goals that we all believe in and want to make a success.

As a sector, our thinking can also be siloed. When GSK forged a partnership with the McLaren Formula One racing team to help improve our business, it made a huge difference. We weren’t sure what to expect at the start, so we had to believe. We created a joint team to look at performance in our packaging areas for potential improvements. The idea was to use the race mentality. First, we had to define what "winning" looked like for us: "A day when no one is hurt, a day when we don’t have any defects." Then problem-solve to achieve this goal, like a Formula One team. We got improvement within days, thanks to the completely fresh perspective they brought.

The third obstacle is our sector’s tendency to focus on bigger, long-term-change projects rather than short-term improvements that can deliver quick wins. We need both. One of the benefits of having a consumer health care business within GSK is that this encourages the pace of change and execution associated with FMCG (fast-moving consumer goods), delivering results more quickly. Rapid results also create energy and confidence in your organization.

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