Cut down, collaborate and focus on the customer

Pfizer’s Kim Sendall lets NGP in on his vision for the manufacturing facility of the future.

“When you’re working with high potential drugs, it could be very expensive if you something goes wrong and it takes 10 days to shut the facility down”
-Kim Sandell

For Kim Sendall, building the ultimate pharmaceutical manufacturing facility is not about bricks and mortar or machinery – it’s about people. Sendall, who is Pfizer’s Director of Manufacturing, knows what he’s talking about. He is currently project director for a new biotech plant under construction in Strängnäs, Sweden. He believes that of manufacturing’s four elements – equipment, product material, processes and people – people are the most important.

“If you have a newly constructed facility or an old facility, you’re more or less stuck with the equipment. It sits there. So you need to work around with processes, or you need to find clever ways of utilising people better, such other ways of working shifts, for example. It’s also about empowering people to feel that, ‘I can do my job and take decisions within my responsibility.’

“The people element of it, that’s the most important thing; that’s where you can make a difference. Everyone can buy the right equipment, everyone can get a fairly good process, but if you don’t have people who are passionate about moving the process along and developing it continuously, you will not be leading edge.”

Once you have the right people in place, the next issue to be tackled is the constraints of legacy equipment. Sendall says this can be overcome by building in flexibility from the very beginning, “When we’re building a new facility, it’s very much about building in flexibility in line withour knowledge. Of course there will still be constraints, but it’s mostly about getting to a point in the construction of a facility where you are very aware about your bottlenecks and your constraints so that you have made conscious decisions as to what you end up with.

“When you have constructed the facility, you will then know the ways out of potential future problems. You have to do a really big, good planning exercise before you start building so that you know if you build it like this, you will have a bottleneck in say, step one. Or if you do it like this, you can remove the bottleneck in step one, but then step four becomes the bottleneck. You have to think forward and see where this facility could go in the future. If you have a consciousness about that, it’s much easier to work around. Otherwise, if you build something for a certain purpose described in the business case at that point, you can be sure that it will change in five years, and then you don’t have the flexibility.”

Manufacturing is an integral part of the pharmaceutical process, but it is often not considered thoroughly enough in the design process. Sendall says this will change, with the facilities of the future being designed to be multipurpose. “You have to have someone with a good imagination and good knowledge about what might come, and you have to make some educated guesses, so that you don’t focus solely on that one product. Building a dedicated facility is a terrible waste of capital. You need to look at a broader perspective, but you still have to go back to the process that you’re aiming at to start with to make sure that that you can reach the quality attributes you need.

“One of the most crucial elements is having customer input from the beginning. You need to think about things like user demands and flexibility when the design is still only on paper. If you do it later, you will already have built in restrictions that might be less desirable. It’s about getting a customer focus: you need to have the customer on board in the product early so that you can make the right decisions.

“Otherwise, uou might miss the long-term goal; you might not give enough consideration to lifecycle costs, for example. It might be wise to spend €10 million on something rather than €1 million, because if you choose the €1 million engineering solution, it might not help in the long run, because you might need to spend €20 million on people in the following 10 years because you need a complicated workaround.”

Breaking down silos
Sendall says that part of the innovation process for the future of manufacturing will involve encouraging people to think in a broader context. “It’s very much about getting a mixture of people and trying not to look at the departmental things. It’s about saying, ‘I’m working for the capital product, so I’m focusing on my parts in the capital things. I look at equipment.’

“But you also have to have someone coming from the process side talking to these people and saying, ‘Yes, but if you do it like this, it will be much more beneficial from a process point of view.’ It’s all about mixing a team, and as a manager being proactive in that and bringing in a cross-functional team. Somehow you have to, as a manager, force people together, because it’s very easy to sit in your silo and say, ‘I’ll do my work and he’ll do his.’ And that’s not the way of the future.

One concept in streamlining that many other industries have introduced is continuous manufacturing, but Sendall points out that this method is not particularly suitable for the pharmaceutical industry, which tends to stick to the batch process. “We are working with E. coli fermentation, for example. E. coli is a really rapid organism to work with: it grows for 48 hours, and after that it has generated so much cell mass, you can’t handle it within the equipment. You have to have a batch break. I think we’ll still stay with batches for a long, long time. You do need to have a process where the batch flows smoothly through the system so that you don’t have to wait to empty the whole facility, but until batch one is done, you can’t start batch two. It will never be a fully continuous process.

“The other big drawback of having a continuous process when you’re working with fermentation and high potential drugs, is that you have such enormous value in the facility, it’s nice to have isolated batches if something goes wrong. It could be very expensive if you have continuous operations and it takes 10 days to shut the facility down. That might mean you have lost several million euros worth of product.”

There are those who say that the pharmaceutical industry should not only break down silos within its own walls, but that it also needs to reach out and learn from other industries when it comes to introducing more future-oriented manufacturing processes. In much the same way that Novartis has said it wants to become the Toyota of the pharmaceutical industry, Sendall says that his company can learn from other manufacturers on its home turf.

“I think that’s the same thing for us. We are fortunate being in Strängnäs in Sweden; we are close to Södertälje where we have Scania, the big truck manufacturer, and they are really advanced in Lean manufacturing. The pharmaceutical industry is way behind on this, way, way behind, maybe 15 or 20 years. We definitely have to step up our performance.

“We can make a quick comparison on the existing processes we have today and the existing facility and compare that to the new facility that we’re building up now. We will produce the same products, but we have a new generation of process. Today we need to handle about nine batches to get to one final batch of a certain size. In the facility of the future, we will be able to handle one batch all the way through with a three times higher yield. So we are replacing 27 batches with one batch.

“Those are the things you have to do to move forward. You can’t just have a lab model that you scale up 1000 times; you need to look at around step one – what effect does that have? – to step two, and try to get into a free-floating thing so that you can have a batch flowing through.

“Today we have to have a lot of intermediate steps, and that wastes a lot of time, because you need to collect a product, and then start the next step. But in the new facility, we can start from point A and run all the way to point Z without having any stops. We’ve been more moving toward that and looking at less intermediate steps and trying to gain yields as well – and of course, looking at waste time.

“We will reduce the lead time on these processes with about 75 percent moving from the old facility to the new facility, just because it’s a more streamlined process and we can streamline work around it as well. Just imagine handling 27 batches at the compared to one; it’s a huge impact.”

Reining in spending
Sendall believes there is no need for enormous capital expenditure in creating and building these new labs. “That’s the beauty of it: the new processes don’t have a new specification. They use the old specification, so we can use all the old methods. The analytical labs stays intact. You use the old labs for doing the new processes, so what you are doing is freeing up a lot of time in those labs for doing more production or using personnel, wherever the needs are. The best thing would be if you could have more product coming in and you can do even more with the same amount of people. Otherwise, you would have to take away people if the volume stays the same.

“The dilemma you end up with when you are working with operational excellence is you have to be very careful that you don’t start to use it solely as a savins exercise, because that takes away all the engagement from people. They will start thinking, ‘If I do good work here, that might mean that I don’t have a job on Monday.’ It’s very important that operational excellence is about freeing up capacity and then trying to fill that capacity.

“It’s not about freeing up people and taking them away and minimising the organization. I guess that’s why companies like Toyota and Scania have been really good at this, because they have been working from one capacity base, and they needed to increase capacity. It has not been about being more efficient in that way, but they gain all the efficiency anyhow. It’s all about doing more with what you have.

“I’m a bit worried about the turmoil in the pharmaceutical industry now, because it’s more about doing – or saving money, and even at Pfizer this operational excellence initiative that we’re running now more or less started as a saving exercise. That doesn’t empower people, and that doesn’t engage people because in the course of the work, you might lose your job when you are making improvements.”

Given this, what other metrics can we then use to measure operational excellence, because everyone says Cost is the driver, because it gets the executive buy-in. How can we ensure operational excellence moves in the way of empowering the people to do well without threatening their livelihood?

Sendall says it’s about showing what you can do with the facility and the equipment you have. “Say that you can be so efficient so that you can free up 70 percent of the capacity. Then it’s about, for management, filling that capacity; it’s not about trying to shut it down or laying off people. We need to find something to fill it with, and if we don’t have products in our own pipeline, we can try something else, such as going out to do contract manufacturing.

“We can show that we will free up this capacity, but that it should be used for something else. Otherwise, you won’t get those great benefits that you might think, because you’re still saving money, but you might spend things in capital to make these improvements, and you’re still stuck with the same volumes. All that goes back to the same volumes, and you don’t get the big leverage on the improvements that you would get if you could still utilise all the capacity you have.”

In the end, Sendall is looking to make Pfizer a leaner, more flexible manufacturing entity. “We would like to fill up what we have in spare in terms of other products, and if it’s not a Pfizer product, it will be great if we could find a third party, and we’re working on those strategies. It’s not all about saving, saving, saving, cutting away and cutting away. Freeing up capacity is more the thing; filling that up.”

And ultimately, Sendall says, the big drug companies can use this to gain back ground in the battle against the generics. “You can take the electronics industry as an example,” he explains. “There are a lot of joint ventures around facilities where they are producing the same kind of microchips, but it might be Phillips or Sony or someone else using the same facility; the only thing you are changing is the layout of the plasma screen.

“In the same way, why not have a growth hormone production site where you have a joint venture of five big companies making growth hormone. Why should they all have separate facilities? If you consolidate that into one facility, you get much better gain out of that facility and you might utilise the capacity up to 90 percent instead of having five facilities that might be used to 50 percent.

“We need to go to more alliances like that to, into the future and think in a much less conventional way. If you look at all other industries, this is not something new. But in pharmaceuticals we have been too protective.”

Once it opens up to these new ideas, pharmaceutical manufacturing will never be the same again, and may even prove to be the secret weapon that helps big pharma stave off generic competition and come through the recession more or less intact.

Kim Sandell is Director of Manufacturing at Pfizer. He is responsible for the end-user representation and start-up activities for the new biotech plant being constructed in Strängnäs, Sweden.