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Striving for Sustainability

Sustainability is an increasingly important topic for the entire world. Every person – and every industry – must play their part. What does this mean for pharma? Is it all about switching away from fossil fuels or is waste a more important factor? And, while we’re asking questions, just how many different forms can “waste” take?

Brace yourself for (some) answers, as editor Stephanie Sutton quizzes four experts from different corners of the industry on the importance of sustainability, protecting the planet, and what actions companies can take – both small and large – to help make a difference. 

Watch the recording of the ensuing discussion over on Youtube or read the edited transcript below.

Why is sustainability getting more attention?

Peter Soelkner (Managing Director, Vetter Pharma-Fertigung): Right now, our industry’s footprint on the environment is quite massive. We have to be honest with ourselves here. The pharma/biotech industry’s footprint is almost equal to that of the automotive industry. We have to take a close look in the mirror and consider what we can improve.

On the other hand, there have been some really good initiatives. For example, the EU Green Deal, which set an imperative that, by 2050, the EU should be climate neutral. In Germany, we’re using legislation to try to achieve this goal five years in advance.

At Vetter, we recently released a new strategy called Vetter NExT 2029. Sustainability is heavily embedded in that strategy because it is all about balancing economic performance with social and ecological responsibility.

The pandemic pushed pharma and biotech into a corner, forcing us to reflect on what we’re doing. When people look back on the industry five to ten years from now, they’ll understand that right now – or several years ago – was the time to act and start the first initiatives to reduce our footprint. From our own real-life example, I know that we can make an effort to drastically reduce our emissions. Yes, it costs money, but in the long run, you are much better off.

I’ll share a couple of examples that we have already started on. There’s our biomass power station which we run alongside local farmers, and we also use photovoltaic and geothermal initiatives.

Sometimes you find yourself between a rock and a hard place just to stay in compliance with all the harsh regulatory requirements in our industry. There are times when you have to stay between 2 to 8°C, and times when you need to keep air conditioning units running, and so on. There is definitely a lot of energy consumption. The same is true when it comes to recycling materials. What do you use? What do you discuss with your customers in the first place?

What is for sure is that right now we have a high degree of environmental consciousness, and we have to use that to achieve a balance between the environment, economic performance, and social responsibility.

Katie Murray (Technical Director, CPI’s Medicines Manufacturing Innovation Centre): Recent events like the COP26 climate change conference have increased awareness, too. There's an increasing sense of urgency now. People know that we actually need to do something, rather than endlessly talking about it. It’s illustrative that many of the large pharma companies have actually set out bold targets for net zero carbon emissions, are actually committed to achieving them, and are demonstrating that they can do it. I believe that they’ll bring the rest of the industry along with them.

Brian Peutherer (HSE Director, Sterling Pharma Solutions): It’s true that industry and government are increasingly aware of the need for action and national initiatives, but in the years to come I think that they’re both going to face more pressure and more challenges from the public. Ultimately, the public are the consumers of our materials, and that gives the consumer some power.

I think the public are now much better educated in regard to sustainability and climate change, and this then translates into the investment side of our businesses. We are certainly seeing drivers toward sustainability within the industry, but the pressure from financiers is having an effect too. This is right and good, causing the industry to sit up and make some changes. As Katie said, now’s the time.

Jnanadeva Bhat (Head of Formulation R&D – Pharma & Nutra, ACG Group): It is important for us to understand that the pharmaceutical industry mainly deals with chemicals, solvents, water, etc. As with any other industry, it’s very important to focus on waste management and sustainability. We can recycle a lot of materials used in the manufacturing industry, and we should emphasize more on greenhouse gases generated during these processes. It is imperative for us to assess the problem from all the different angles.

What inspiring things are happening across the industry? Has anything caught your eye?

PS: I would point to the United Nations’ 17 global sustainable development goals. At Vetter, they guide us on how we developed our own environmental program.

Next, I think we are all aware of the Paris Agreement; 196 nations were present, and 189 of those nations ratified the agreement. Now that we have seen the US come back on board, we really should be able to limit global warming by 1.5 °C and reduce our emissions andgreenhouse effects by 45 percent compared with 2010 levels.

Another thing I would point to is the Pharmaceutical Supply Chain Initiative (PSCI). That is really relevant for Vetter as we are a global business that manufactures high-end biopharmaceuticals, fill them into containers and ship them to globally acting pharma and biotech companies. A company such as ours really needs to pay some attention to efforts like PSCI. Examining PSCI’s requirements is a way for us to form our own policies and improve.

Of course, it’s not all about policy. Personally, I am not a big fan of simply creating laws and obeying them. Changing the DNA and the mindset of a company is more important to me. We’re facing challenges, but they are challenges we can overcome.

KM: At CPI, we’re currently looking at technologies that will reduce waste, energy consumption, and so on. One of them is a continuous direct compression technology for making tablets, designed to replace the current state-of-the-art processes which typically use a granulation step that adds more energy to the process. You can do it dry or you can do it wet, but either way, this new continuous method allows for a much smaller footprint in both equipment and energy. We're also applying a digital twin to the system, which means that during the process development stage, your experiments can be carried out virtually. And that means that they can be completed really quickly, without eating up any materials.

We are also looking at a digital quality dashboard. Currently, the batch release of final products for medicines can take many weeks because a qualified person has to set out and retrieve relevant information from many different systems. In our digital approach, all of that information would be held in one place, dramatically speeding up that batch release process. This would then shorten the supply chain significantly, heavily cutting down on waste.

We are also looking to run our facility more efficiently. Right now we’re working with another company to explore some smart technology for controlling the airflow rate in clean rooms. At present there tends to be a fixed number of air change rates regardless of what's going on in the room, and it's designed to cope with the maximum load you will expect – which is typically people going in and out and moving around rooms, generating particles. This technology counts the number of particles and then uses that to control how much air we need to put through the cleanroom rather than just having a blanket number regardless of what’s going on. This would lead to big savings in energy.

JB: I would like to add that one of the most important aspects of sustainability from the industry perspective is exploring packaging materials. Using biodegradable primary packing material is a very good green initiative. Apart from this, in the pharmaceutical industry, liquid waste management presents an opportunity to move towards sustainability. Implementing zero liquid discharge is a very strategic move that would add to improve sustainability.

I would also like to mention another great initiative – the switch over to capsule-based dry powder inhalers, as opposed to HFA-based propellant. HFA-based propellants cause greenhouse gas emissions and harm the environment. Capsule-based dry powder inhaler is a suitable drug delivery to the lungs without hampering the environment.

BP: My colleagues have done a good job there in summarizing a number of the challenges and opportunities in this area. To sum up, I would say that any organization hoping to become more sustainable needs to look at itself, and identify what sorts of initiatives would suit it best.

At Sterling, we’ve recently carried out just such an exercise. We’re an API manufacturer, handling a lot of organic solvents and chemicals, and a lot of aqueous materials. It’s true that a pharmaceutical active ingredient manufacturer does create a reasonable amount of waste – though green chemistry practices can help.

Within our business, we decided that the sustainability challenges we face are around energy and waste. And we’re now looking at implementing anaerobic digestion, which  allows us to take some of our most heavily contaminated water waste streams – and even potentially some pure solvent streams – and treat those using anaerobic digestion to create a biogas or biomethane, and then inject that back into the national grid. The process generates a fuel stock from waste material, manages our liquid waste disposal, and also helps with our energy management challenges.

Such initiatives can tick a number of sustainability boxes within one organization – and use a single investment to tackle problems across three or four sites. 

As we’ve heard, waste management, energy management, and the supply chain are the three biggest contributors to our carbon footprint, and those are the things that we need to tackle.

Meet the speakers

Brian Peutherer, Vice President of Environment, Health and Safety, Sterling Pharma Solutions

Brian Peutherer graduated from the University of Newcastle upon Tyne with a BEng in Chemical and Process Engineering and an MSc in Clean Technology and Environmental Management.  He began his pharmaceutical career as a process engineer for Chirex in 1997, before moving on to work in process safety management, and in 2004 joined Pfizer in Morpeth – later Piramal Healthcare - where he led site EHS Management. He joined Sterling in 2016, where he has been instrumental in building the Dudley, UK, site’s EHS team and moving the site towards its ESG aspirations and ISO certifications.

Katie Murray, Technical Director, CPI’s Medicines Manufacturing Innovation Centre

Katie Murray is a chemical engineer with over 25 years’ experience in the pharmaceutical industry. She started her career in process development and scale-up roles with both Merck in the US and AstraZeneca in the UK, before moving to technical leadership roles in the deployment of technology into large capital projects, also at AstraZeneca. Her expertise covers both drug substance and drug product development and manufacture.

Jnanadeva Bhat, Head – Formulation R&D (Pharma & Nutra), ACG Group

Jnanadeva Bhat has been associated with the pharmaceutical industry for almost 3 decades. As a product formulator, he has worked on various dosage forms, including tablets, soft gelatin and hard capsules, injectables, and lyophilized formulations. At ACG, he heads the formulation R&D lab where he primarily leads new product development projects and customer interface. 

Peter Soelkner, Managing Director, Vetter Pharma-Fertigung GmbH & Co KG

Peter Soelkner has been in his current role since June 2008. In 2009, he was also appointed Managing Director of Vetter Pharma International GmbH, the company’s marketing and sales organization. Soelkner graduated from the University of Dortmund, Germany, in 1992 with a degree in chemical engineering and earned an MBA from Columbia University, New York, in 2001. Before joining Vetter, he held positions in Germany and North America at Sartorius AG and Sartorius North America Inc in R&D, marketing, key account management, and general management roles. At Vetter, from 2003 to 2007, Soelkner managed the company’s key account program and global end-to-end supply chain. He left the company for a year to serve as Vice President of global key account management at Sartorius Stedim Biotech (USA), before returning to Vetter in 2008.

What are the challenges to actually doing something about these problems?

PS: There are definitely challenges. For one thing, we have to comply with a whole array of regulatory requirements that commit us to a high level of consumption. For example, aseptic manufacturing and cold chain are both energy intensive but essential to the safe supply of injectables.

Therefore, our sustainability strategy is to transition to greener forms of energy as we have no wish to cut corners around regulatory requirements. We looked into implementing photovoltaic and geothermal energy on our own sites, and for buying energy we looked into hydropower as our corporate headquarters is relatively close to the Alps. Across the alpine border in Austria there are numerous hydroelectric initiatives.

Additionally, we looked into recycling and consumption of materials. A great deal can be done here; for example, by switching to electronic paperwork. A batch of 100,000 syringes, for example, comes with somewhere between 1,000 and 1,500 pages of documentation. As you can imagine, if we manufacture 1,000 batches a year we would go through a lot of paper. 

Watching current events can also help you sort your priorities. The war in Ukraine really underlines the fact that we need to become independent from fossil fuels as quickly as possible. Switching to sustainable energy might be more expensive in the short term, but natural gas prices have gone through the roof. For those unswayed by a purely ecological argument, the economic perspective is increasingly compelling.

KM: From a process perspective, as you explore different ways of manufacturing the medicine, you start to raise many questions about potentially changing the quality of the final product. And so it takes a lot of time, a lot of data, and a lot of confidence to switch from one process to another for an already established product. It’s easier when products are in development, though the risk remains for project teams, because it’s not what they’re used to doing. To respond to that element of risk, we need to build up collective confidence in new technologies and support the project teams that are introducing them, while also working with the regulators and aligning on what we’re trying to do. We want them to work with us, rather than get spooked by changes and reject us out of hand.

BP: Katie’s point is very important. In the pharmaceutical world, the regulatory regime is essentially averse to change. This brings challenges – namely cost and risk. All of that has to be managed, and I think it produces one of pharma’s biggest hindrances – fear of breaking away from the status quo. “We’ve always done it this way,” is the prevailing attitude. “Batch chemistry has always been like this.” “Formulations have always been like that.” We face challenges in many areas, but in each of those areas we need to break free.

My company is a contract manufacturing organization, and we have a large number of customers across the space – from preclinical work through to the commercial stages. At each different stage, there are opportunities for both regulatory and sustainability risk management, but the funding and support available during those stages are not uniform. In the early stages, we can design chemical processes that do not become inefficient and unsustainable during commercial success and scale-up. As a contract manufacturer, our job and challenge is to push our requirements for more sustainable operations up and out towards our customers, and get them to buy into the spirit of sustainability as well. We also need that same spirit to cascade down through the supply chain to the people who are feeding us with materials.

What concrete steps should pharma companies that want to make a difference prioritize?

JB: At my own company, we are looking at the use of automation and continuous manufacturing. We believe we can reduce waste at the early stages in a relatively straightforward manner. This is something that can be replicated across the pharmaceutical industry, and something which confers both economic and green benefits. 

KM: Here, I’ll start by pointing out a problem: science is bringing us new manufacturing challenges. In recent years, we’ve seen quite a few developments toward an ever increasing complexity of molecules (for example, drug antibody conjugates). And this increasing complexity brings more and more manufacturing steps that lead to a higher carbon footprint.

However, this could be offset by taking a whole lifecycle and patient pathway approach, which allows us to treat patients with much more effective medicines while retaining in an overall sense of – and reduction in – carbon footprint per patient. I think we need to take a look at this holistic view, rather than simply focusing on manufacturing.

I completely agree with all the points that this table has made concerning efficiency, but I also think biology deserves our attention. For example, there are now self-amplifying RNA approaches that require smaller manufacturing runs and, therefore, a smaller carbon footprint.

I also think the supply chain is worth discussing at length; even simple medicines can have extremely long and complex supply chains. The pharma companies own the segment in the middle, but we also have raw materials, crude API, excipient supplies, manufacturing, distribution, prescription, and disposal. On such a complex chain, who do you hold accountable? 

The more connected and visible you can make the major carbon footprint segments of that supply chain, the easier it will be to increase efficiency and therefore reduce waste. At the moment, it’s extremely difficult for a CMO to electronically communicate with a big pharma customer, for example. You simply do not have such visibility across the supply chain. The better job we can do of connecting those supply chains and making them as efficient as possible, the greater the sustainability benefits we’ll see.

BP: From my point of view, companies should focus on measuring their own operations. “What gets measured, gets managed.” It’s a very old adage, but it’s very true in the world of sustainability. It sounds like every company represented on this panel is on the ball here, but some others aren’t there yet.

Measuring isn’t just a box to be ticked. You’ve got to make it part of your company culture to drive the business and also individuals within that business.

After measurement, you’ve obviously got to invest in the things that will have a big impact. It could be in energy, waste, or the supply chain – companies should choose whatever suits them. It was really encouraging to hear Peter talk about how his business is working towards hitting carbon zero. That is great, and other companies need to follow suit. It’s the same as every other business priority – measure it, work out what to do, build the culture, and make the change. That is what businesses need to do, whichever sector you’re in.

PS: From the perspective of a CDMO, becoming more environmentally friendly and reducing your footprint should be a prerequisite.

In the last couple of years, big pharma companies have definitely adapted and bought into that concept. As a supplier to the industry, you get a lot of audits in areas such as environmental health and safety. If you want to serve the market long-term, you have to be proactive in your compliance.

As Katie mentioned, the next era of medicine is arriving, and it is very interesting. Third- wave biotechs, individualized medication, and genomics are going to bring even smaller patient populations to the fore. In my worst-case scenario, every patient would need their own little fermenter and filling equipment and so on. I think we really have to ask ourselves how we would cope. How do we come up with intelligent ways to improve the entire manufacturing process?

In my previous life, I worked for an equipment supplier. If you asked them that question 15 years ago, they would have told you that we were heading into a future where everything was going to be single-use. In our reality today, you do find widespread use of fast hybrid processes that allow you to quickly get medications to patients. But there are also many people going back to fermenters which are – all of a sudden – made of stainless steel again.

It’s a similar situation with our compounding containers which we use again and again rather than committing to single-use. These trends raise another question: How do we maintain a balance between stainless steel and plastic? To answer that we have to look into the entire production process.

Awareness around the responsibility we have towards the planet and society is growing in this industry – and that’s good to see.

Any closing remarks? 

PS: I’d like to flag some of the little things. Sometimes smaller companies cannot afford to invest in the big programs. But there are other ways – cycle-to-work schemes, for example, which saw a big uptake, as the safety of using public transport became questionable. 

Other eco-friendly measures are easy to implement. At our new office building, which houses around 1,000 employees, we have set up a waste collection system; everybody is responsible for emptying and sorting their own bin, and I think that drives a certain awareness. We also have motion detectors that ensure nobody accidentally leaves a light switched on. All these little things add up and help to change the mindset and DNA of the company. It is my hope that such measures become more and more normalized.

JB: The treatment, disposal, and handling of unused medicines is a serious question. Someone somewhere has to take the initiative in managing this issue. I’d also like to underline the approach my company takes in promoting sustainability in all our partnerships, and across several of our programs. At the end of the day, I’m glad that we have so many insights across different industries and new initiatives to talk about on sustainability.

BP: We’ve had a very diverse discussion, and I think that’s reflective of the vast wealth of different businesses making efforts in sustainability. The key thing now is for all business leaders to call on their organizations and work out the right course of action. My hope is that those actions will be based on sound measurements and involve the management of energy, waste, supply chains, and the encouragement of people and their positive behaviors. Last of all I’d say that we can’t just “get started” now. We are running out of time. Industry and governments need to step up.

KM: My opinion is that we’re probably going to need sustainability targets to gain a license to operate – where failure to hit them shuts you out of the market. I also think that working together across supply chains will be crucial, so I was really glad to hear Peter talk about that. Companies need to realize that these measures will increase costs on CDMOs and other operators, and adjust for that. A combined collaborative approach that recognizes the challenges and sets expectations between the different nodes in the supply chain will be really important. Last of all I’ll just say: I really enjoyed this discussion!

Watch the recording of the discussion on Youtube

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