Unit Operations / Op Ex & Lean Six Sigma / Facilty Design & Management

Pharma Sustainability Is on a Roll

Drug industry environmental stewardship projects are becoming more sophisticated and challenging. Here are examples from AstraZeneca, Bayer, DSM, Pfizer, and EMD Millipore

By Paul Thomas, Senior Editor

Drug manufacturers as a group have a good track record of environmental stewardship. Companies like J&J, BMS, Allergan, and Amgen, to name just a few, have been going green for years and regularly rank high in studies of corporate sustainability. Most manufacturers have thrown themselves headlong into, for instance, green chemistry and water- and energy-reduction measures to shrink their carbon footprints and chip away at operational expenses. (See, for example, “What’s Your True Green?” and “Pharma’s Green Evolution.”)

But, has the proverbial low-hanging fruit been picked? What’s next? Drug manufacturers are now undertaking more challenging green initiatives. What follows are snapshots of projects under way at four leading manufacturers—AstraZeneca, Bayer, DSM, and Pfizer—which show how pharma’s sustainability efforts are maturing. These initiatives can echo throughout the supply chain. In one case, a pharma supplier, EMD Millipore, is working with its top biopharma customers to ensure that it, too, reduces its environmental impact.

AstraZeneca: Monitoring API Emissions

The issue of Pharmaceuticals in the Environment (what some call PIE) has garnered plenty of media attention in the past several years, most of it negative. Fortunately, it’s an issue that groups like PhRMA, regulators such as the U.S. EPA,  and individual manufacturers such as AstraZeneca are now taking more seriously than ever. Most of the concern with drugs in the environment revolves around consumers who either excrete ummetabolized active ingredients or dispose of unused medications into sewage systems.

APIs entering the environment via effluent from manufacturing facilities, while less of a concern, is still significant. A team of AstraZeneca researchers headed by Richard Murray-Smith (based in Brixham, U.K.) have developed what they consider a proactive and risk-based approach to stemming potential API pollution from production sites. The approach identifies acceptable long- and short-term concentration levels—known as environmental reference concentrations (ERCs) and maximum tolerable concentrations (MTCs)—in the groundwater near facilities. It builds on traditional methods for monitoring, but also includes significantly more information regarding potential toxicity to primary consumers (e.g., algae), secondary consumers (e.g., fish and frogs), and indirect consumers such as fish-eating mammals and humans.

The approach—detailed here—also takes into account significantly more data than is customary and relies upon predictive modeling to help AstraZeneca and other manufacturers prioritize which types of emissions at which sites are of greatest concern.

“Most pharmaceutical manufacturers have good control of their discharges,” says Murray-Smith. “Ours is just one possible approach which we have published because we believe it is worth sharing and shows that we are taking the issue seriously.”

“The pharma industry has had some bad press in recent years concerning API discharges,” he adds, “which has often been frustrating because we have some excellent examples of good practice and some good stories to tell. We hope that our ERC approach will stimulate debate on how safe discharges can be defined in practice.”

AstraZeneca’s sustainability efforts have been supported from the very top of the organization. “This has been the single most important factor for ensuring successful implementation of our approach,” Murray-Smith says.

The results so far, he says, are not so much surprising as they are reassuring. “All of our own sites are operating within our ERC limits, and we are now starting to share our approach with our suppliers.”

Bayer: Keeping Data Cold and Green

Bayer has large and diverse sustainability initiatives. A recent unequivocal success has been its Green IT program, which aims at reducing the energy consumption and environmental impact of all facilities, but particularly its data centers in Leverkusen (Germany), Singapore, and Pittsburgh.

Bayer
Bayer’s Dr. Peter Beck and
Klaus-Rainer Nyga in a cool
room in Leverkusen
.

Part of the program involves the virtualization of servers—relying upon web-based cloud services (provided by Amazon, for example). In 2011, it virtualized some 800 systems and thus eliminated a large number of servers, says Thomas Schilling, who coordinates the company’s Green IT activities. A year earlier than planned, the company has improved energy efficiency in its data centers by 20%.

Another part of the program involves the cooling of servers and data processing equipment via “cold-aisle containment.” Schilling discussed some of these efforts recently. (Here’s the full interview.)

PhM: How has Bayer virtualized its IT operations and what have the energy saving and other benefits been?

T.S.: The Bayer IT operations are based on a very broad virtualization strategy that not only addresses the server hosting itself, but also the virtualization of storage, network and applications. Nevertheless the core contributions to the energy savings come from the consolidation of a broad landscape of physical servers into a virtualization farm of larger x86 servers hosting several thousand guest systems with Windows and Linux operating systems. This aspect alone accounts for nearly 50% of our efficiency target or an overall efficiency increase of Data Center IT by almost 10% since 2009. On top of this, hosting costs can be reduced due to savings in hardware, network ports, power, cooling, and rack space.

PhM: You’ve also worked on optimizing the cooling of your servers and IT equipment via “cold-aisle containment.” Is this a fairly straightforward process with a quick return on investment (ROI)?

T.S.: The cold aisle housing is in fact a very cost efficient means of reducing the cooling energy required in our existing data center server rooms. It offers an ROI between two and three years in most of our cases. The cooling energy required for these rooms could be reduced by up to 60% via additional optimization of air flow rates. We already had a good starting point of cold / hot aisle separated rack placement with multiple compartments in a dark room concept where we also separated different functions like server, storage, tape libraries and network where possible. Therefore we could optimize the use of CRACs (computer room air conditioners) and thermal conditions for standard server and hot spot scenarios. And this measure could be used even if you do not have the option for a green field approach.

PhM: Bayer is using more videoconferencing to cut down on global air travel. This obviously makes sense from a sustainability point of view, but is there a way to quantify the cost and energy savings, CO2 needs subscript for 2 reduction, etc.?

T.S.: This is, in fact, very difficult to assess. Nevertheless, we track the utilization and coverage of our telepresence and videoconferencing facilities and we introduce a full-service booking and support package to provide a convenient experience to our internal users.

DSM: An Enzymatic Approach to Sustainability

As the world’s population expands and resources become more scarce, manufacturers are exploring the field of “white biotechnology” for solutions. White biotechnology uses natural microorganisms and enzymes to enhance the production efficiency of fuels, foods, chemicals and, of course, pharmaceuticals—reducing the environmental footprint of manufacturing processes. Some of the benefits during production:

  • Less usage of water, energy, and solvents;
  • Lower waste and CO2 emissions;
  • Reduced operational costs.

DSM Pharmaceutical Products has experimented with white biotechnology, including in the production of what it calls “Synthon B,” an alpha-substituted chiral ester that one customer solicited in large amounts.

During route scouting in the early stages of development, it became clear that a chemical route (a diastereomeric resolution of a racemic mixture) would not work from a cost or throughput-time perspective. Nor would it be environmentally desirable: A lifecycle analysis concluded that an enzymatic route would significantly reduce the process’ impact upon global warming and other environmental factors.

Screening of enzymes revealed that a process dependent upon pig liver esterase (PLE) would work, but this presented obvious problems for a pharma application, says David Ager, principal scientist at DSM: PLE was of animal origin (and not kosher or halal), had an undefined mixture (i.e., different isoforms) and variable quality from batch to batch.

Wild type PLE is a mixture of isozymes, Ager explains. "We took one of these and determined the amino acid sequence," he says. "This was used to provide a DNA sequence that was then synthesized chemically." The DNA was then put into one of DSM’s proprietary PluGbugs—microorganisms not of mammalian origin that are designed to overexpress proteins. The result was a process that gave excellent performance in the synthesis of Synthon B and significantly reduced the number of operations. With a solution in hand, Ager says, "We went from lab to production in a few months."

The enzymatic method is faster and uses cleaner solvents and materials, so the carbon footprint is smaller, Ager continues. In addition, the “off-isomer” can be recycled.

The work on PLE has led to the development of other isozymes with different selectivities. “We will continue to see the development of enzymatic methods for pharma applications where chemistry struggles,” Ager says. For large-scale manufacturing, he adds, the use of enzymes is already leading to more cost-effective and sustainable processes.

Pfizer: Empowering the Community

Pfizer has many and various sustainability projects in progress worldwide. The company has leveraged green chemistry to, for example, reduce the carbon dioxide emissions of global Lyrica production by 80%. The process for making the drug’s API, pregabalin, has been revamped to rely upon biocatalysis using natural enzymes. In Puurs, Belgium, it has constructed a 45-story wind turbine that will generate 12% of the site’s power and will pay for itself in four years.

Pfizer Newbridge
Members of Pfizer’s
Newbridge green team.

But sustainability requires not just bright ideas and changes in corporate behavior but also employee buy-in and changes in mindset. To this end, Pfizer’s Newbridge, Ireland facility has embarked upon a greening of its site that is as much about employee involvement and awareness as it is any specific project. “YOU Have the Power” has garnered support from employees by focusing on matters of importance to them—energy and water conservation—at work, home, and in the community. Thus, colleagues, friends, and family participate in projects together and become drivers of change.

The success of the program rests upon encouraging all employees to make small but meaningful changes at work and home, leading to a significant collective impact. It might sound a bit simplistic, but the program is working, says Michael Donlon, site lead for Environment, Health & Safety.

In little more than a year, it has achieved a 26% reduction in energy consumption, 14% reduction in carbon emissions, and 11% reduction in water consumption. It is on course to achieve targets of 50% reduction in energy consumption and 40% reduction in water consumption by the end of 2014. In 2011, the site won the Irish Responsible Care Award as well as Ireland’s National Award for Energy Awareness.

Employees at Newbridge feel “empowered to take action and implement real change,” Donlon says. “The only issue we sometimes have is that it can be difficult for colleagues to find sufficient time to implement all the changes that they want to pursue. It’s a very good position to be in.”

For the future, the Newbridge site, too, is evaluating wind energy as well as the use of biomass heating based upon wood chips from sustainable foresting. Workers and members of the community have joined together to plant 10,000 native Irish trees on site, says energy manager Dermot Doran. As the trees mature and the forest needs thinning, excess trees will be replanted in the community.

The “YOU Have the Power” campaign “has rooted itself in the local community by engaging and involving a cross-section of influential external stakeholders,” says Doran.  (Read our full interview with Donlon and Doran.)

EMD Millipore: Giving and Receiving Single-Use Systems

There’s been an ongoing discussion in the industry as to whether the use of single-use equipment and systems is more environmentally friendly than the use of stainless steel. There’s a growing consensus (and some data behind it) that believes single-use is more sustainable. One sticking point has been the disposal of disposables. “It’s such a visible thing to operators,” says Johanna Jobin, the company’s sustainability manager. “They’re naturally concerned about throwing out these products.” Neither landfills nor incineration are ideal options. (See our full interview with Jobin.)

Thus, EMD Millipore is working with five large biopharma to launch a “takeback and recycling” program for used disposable filters and other components. A third-party vendor assists in retrieving and transporting used products to recycling facilities. Recyclables are reprocessed and repurposed into other plastic items such as pallets, Jobin says. Non-recyclable components are sent to a cement kiln and blended with other materials to be used as an alternative fuel source.

It’s a win-win when a supplier can help a customer to achieve sustainability goals, Jobin says. “We wanted to make it as simple as possible to avoid any disruption to their business.” For example, she says, no sorting or separating is required of operators or janitorial staff—the only condition is that the products placed in recycling bins have not been used in hazardous processes.

What ultimately happens to the used single-use equipment and systems once they are retrieved from customers? What percentage of the materials or equipment can be recycled and used again?

EMD Millipore plans to expand the program to the entire U.S. soon, then to its other key global markets.