Magazine Article | July 1, 2010

Environmentally Friendly Strategies For CMOs, CROs

Source: Life Science Leader

By Chris MacKinnon

When it comes to making friends with the environment, most companies are shifting their agendas to focus on ways they can help in the effort. Call it consideration, saving money, or even marketing, but today’s CMOs and CROs are beginning to do their fair share as well by employing processes and systems that are helping the environment.

Heather Keller, utilities manager for Cherokee Pharmaceuticals (an API manufacturer) says helping the environment begins with energy reduction. Keller says energy usage reduction can be achieved in many ways. “The first step is always increasing awareness,” she explains. “Until employees understand energy costs and the impact of their energy use on the overall profitability and success of the business, an energy reduction program will not be completely successful. Education of employees is necessary, as well as engaging them to help implement changes and drive energy reduction projects.”

Setting goals and tracking progress helps to motivate employees to focus on reducing energy. Keller says simple things like turning off lights and equipment when they are not needed can add up to significant savings over time. She comments, “Paying attention to maintenance items like replacing missing insulation on heating and cooling lines and repairing leaking steam traps or air and nitrogen leaks can pay big dividends.” Keller says some simple energy-based projects can include installing sensor switches for lighting, replacing bulbs with more efficient LED or compact fluorescents, and installing programmable thermostats for HVAC units.

Depending upon the type of manufacturing performed, Keller says there are often many process-specific projects that can be evaluated for implementation, such as installing variable frequency drives on agitators and motors, replacing older equipment with higher efficiency equipment (premium efficiency motors, improved fluorescent lighting technology, and higher efficiency energy sources including natural gas), installing temperature and CO2 monitors on HVAC equipment to optimize usage, and capturing heat from steam condensate or other hot process streams. She notes, “Federal and state grants are currently available to support many energy projects, so this is a good time for CMOs to look at where they can make changes to reduce their energy use.”

Based upon rising energy costs, Cherokee Pharmaceuticals increased its focus on energy reduction in 2008 by creating an energy team to drive cultural changes as well as support energy reduction projects. “In its first year, the team achieved $1.5 million in savings [$3.1 million annualized] and won the Pennsylvania Governor’s Award for Environmental Excellence,” says Keller. “In 2009, the team achieved $1.3 million in savings [$1.8 million annualized] by continuing to build upon the initial programs.”

While saving energy has a direct impact on the bottom line, it also has an environmental benefit and supports Cherokee’s goals of sustainable manufacturing, as well as being a good neighbor to the local community. In 2009, for example, 5,651 tons of CO2 emissions were avoided through energy reductions at Cherokee, which is the equivalent of emissions produced by burning 30 rail cars of coal or to the amount of electricity used annually by 784 homes.

Solvent and Waste Reduction Benefits
According to Derek Hennecke, CEO and president at Xcelience (a CRO that provides formulation development, preformulation, and analytical clinical trial manufacturing), the company’s new facility will introduce a number of environmentally friendly and energy saving ideas. ”Along with our expansion, one of the most radical ideas currently being evaluated by our facility manager is putting solar panels on the roof [a total of 25,000 square feet]. Florida doesn’t have many incentives for this, but what it does have is plenty of sunshine,” he says.

Xcelience’s existing facility also has a backup generator that can take the burden off the municipal utility so it does not have to build extra capacity when it is not needed. Hennecke elaborates, “If the city has an unusually high load or brownout, the utility can contact us and ask us to start up our generator and use some of that power instead. That takes some of the burden off the grid to use existing power elsewhere. In our existing facility, we have also invested in a new building monitoring system that has better controls for temperature and humidity. Pharma clean rooms require many air changes, but the new system software will go a long way to reducing the unnecessary load on our HVAC.”

Hennecke says in Xcelience’s industry, one environmentally friendly tactic is using UPLC (ultra performance liquid chromatography) instead of HPLC (high performance liquid chromatography) technology, since the former uses far fewer solvents (up to 95% less). He elaborates, “Some of these solvents include Acetonitrile, Methanol, and Isopropanol. Our existing facility has more than 30 HPLCs that get used continuously, but now we are replacing them with UPLCs. The UPLC units are very expensive, but they have overwhelming speed and solvent-use advantages.” He says this is good for the company because of the heavy focus on method development, where solvent ratios are constantly changing, but he says it’s also very good for the environment.

In terms of reducing waste, Hennecke says Xcelience is currently implementing a new software-based bar-coding system that includes a feature to help with inventory management, which will alleviate the possibility of duplicating inventory. So, by automating this process, Xcelience will be able to reduce waste. “In our facility, we also practice recycling and the separation of streams of waste. In our laboratory, for example, we separate streams [hazardous and nonhazardous] so we can reduce the amount of hazardous waste,” he explains.

Every room in the existing facility also has motion-sensitive light switches and HE (high efficiency) electronic ballasts, as will the lighting in Xcelience’s new facility. Hennecke says they’ve also recently added a brand new 100-ton chiller, which lowers energy costs by approximately $40,000 per year. The 100-ton unit is properly sized for the existing facility. The company previously had two 50-ton chillers, but switching to the new larger unit has proven to be much more efficient. Hennecke adds, “In the new facility, we’ll also be reducing ceiling heights from 18 feet to much smaller heights. This reduction will permit fewer total air changes and a smaller volume of air that will have to be cooled and humidified.”

Process, Packaging, and QbD Benefits
In Pedram Alaedini’s opinion, there are three major ways life sciences organizations are helping the environment: with processes, packaging, and quality by design (QbD). As president of Primapax Biopharma Group (a global life sciences management and technology firm boosting the performance of pharmaceutical development, manufacturing, and service firms), Alaedini says all three components play integral roles in helping the environment.

“If you think of smaller molecule products, for example,” Alaedini explains, “the first step is to manufacture the API, which is a chemical process that uses many solvents. Of course, the more steps you have in a process like this, the more energy is expended. It’s true that the pharmaceutical industry is still in the dark ages in areas like this. But, the industry is currently taking steps to minimize the number of unnecessary steps in processes and also trying to minimize the use of solvents and recycle them as well (and I’ve read some articles recently about how solvents are being replaced with water).”

Alaedini says when it comes to processes, it’s also important to use equipment that is already proven and has a good track record. He adds, “And when you consider old inventory that sits in warehouses taking space and, in some cases, requires controlled room temperature and humidity, this uses a great deal of energy.” Alaedini says people are starting to create leaner business processes in this area as well.

As for packaging, Alaedini says European companies are leading the way by far. He says Europe is taking many steps toward reducing packaging material. Part of packaging is optimizing distribution and shipping, which also saves money and is environmentally friendly as well. And, the third component, QbD, is the systematic process to build quality into a product from the inception to final output. Alaedini says although QbD has, in the past, been applied to pharmaceutical manufacturing and to some degree development, he says this approach can be used to ensure the environment is kept in mind during product design — including formulation, process, and packaging design.

Electronic Source Data Verification Benefits
For Michael Rosenberg, president and CEO of HealthDecisions (a full-service CRO), helping the environment is a matter of putting pens — digital pens, that is — to paper. Rosenberg explains, “When we collect data in the field, one of the things the FDA requires is data accuracy. So, 99.9% of people in this industry write information down. For example, if a person walks into a clinic and I weigh them, the first place that info is written down is defined as a source. Eventually, this data gets entered into a computer, and someone has to check the data on the computer against the source data to make sure the data is still accurate. So, we spend about one third of our study budgets making sure the data is accurate (i.e. source data verification [SDV]).”

To get around this tedious process, Rosenberg says HealthDecisions does SDV electronically when needed. He notes that using a digital pen enables you to collect data at the source. “From anywhere in the world, we have immediate access to data as well as performance metrics — before the patient even walks out the door,” he explains. “When the digital pen is docked, we get an image of the data that is considered source, so we don’t have to send someone out to the field to do source verification.”

Rosenberg says an important change from usual processes is HealthDecision’s ability to more effectively manage sites using this process. “For example, when someone makes a mistake, we figure out why the mistake was made and make sure it is not repeated. This is more of a preventative approach that is stark in contrast to the norms of our industry where mistakes are made and people sit back and wait for the next mistake to happen. We do quite a bit of trend monitoring, which enables us to pick up subtle changes and help sites function better and avoid making mistakes.”

The reflection of that, according to Rosenberg, is that the query rate is about 80% lower than that of a Web-based EDC (electronic data collection) system. He says these systems and processes avoid a great deal of waste that is common in the industry. “For most studies, this approach allows us to reduce travel between one-quarter and one-eighth, because most of the site management is done by phone and more effectively than the usual approach. And, when you think about how much carbon we spend when we send someone on an airplane, that’s a great deal of time and money.”