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Sep 1, 2010 (Vol. 30, No. 15)

Biopharma's Going Green

Drivers Include Sustainable Design, Technology, and Novel Bioprocessing Strategies

  • The Numbers Don't Lie

    Click Image To Enlarge +
    The streamlining of pharmaceutical manufacturing processes could, by necessity, become more environmentally friendly by virtue of reduced consumption of feedstock chemicals and usage of energy, water, and human resources. [oknoart/Shutterstock Images]

    Tina Larson, director of technical development engineering at Genentech, led off the meeting with a keynote address titled, “Lean and Green: Sustainability in Development and Manufacturing.” Referring to sustainability in process development and manufacturing operations, Larson said, “I passionately believe we can do better.”

    She described Genentech’s voluntary participation in the EPA’s Climate Leaders program, its in-house, grassroots Green Genes organization and ECOmpetitions, and the company’s annual EcoFairs, in which employees participate in environmentally oriented community service projects such as beach cleanups.

    These activities and a strong commitment to reducing the carbon footprint, minimizing hazardous waste production, and other environmental initiatives are not only the right thing to do and can yield cost savings, but they can also have a positive impact on employee recruiting and retention.

    Even though water and energy are “relatively cheap” at the company’s South San Francisco headquarters, parent company Roche, which espouses “a very top-down commitment,” voluntarily set aggressive targets for greenhouse gas reduction and modified the valuation factors used to assess engineering projects aimed at improving sustainability to justify their return on investment (ROI), “so it looks much more financially favorable to do the right thing,” said Larson.

    Gathering metrics on day-to-day operations is essential, she asserted, citing the example of water use in one of the company’s pilot plants. Whereas water consumption for a typical 14-day production run was estimated to be about 300 gallons, the actual use was 14,500 gallons. By switching to an existing glycol system for process temperature control, water use was reduced to near zero, saving approximately 565,500 gallons of water per year in this one plant.

    Switching from stainless steel tanks to single-use processing bags for buffer and final product storage and from glass bottles with stainless steel caps to disposable sampling containers in one of the company’s clinical manufacturing facilities also had “a clear impact,” said Larson, yielding a savings of about 20 metric tons of CO2 annually.

    In 2008, Bayer initiated a climate check footprint initiative that assessed the CO2 footprint (defined as pounds of CO2 produced/pounds of product) for each of its sites and products, expanding early assessments of electricity and natural gas use for production activities to include raw materials and transportation.

    A case study focused on fermentation processes at Bayer Healthcare’s Berkeley, CA, site, where Bayer’s factor VIII is produced, identified “quick wins” in utility use reduction, followed by process changes using technology to increase efficiency and reduce cost-of-goods, according to Thomas Daskowski, Ph.D., head of Bayer Technology Services.

    These included increasing the height of chromatography columns (but staying within established process specifications to avoid the need for re-evaluation), which is predicted to increase yield by 5%, saving millions of dollars and reducing the carbon footprint of this unit operation by about 3%.

    Similarly, changing from a fed-batch fermentation process to a three-month, continuous process using a hybrid membrane module, with increased aeration and cell density capacity, is expected to yield 60% more product from the same fermentation volume and reduce CO2 emission by at least 90%.

    Mark Butler, a senior vp with Integrated Project Services, provided a real-world example to demonstrate that it is not necessary to build a new facility to take advantage of significant cost and energy savings possible by incorporating sustainable equipment and operating practices.

    A biopharmaceutical client that chose a $30 million renovation project over building a $300 million new production plant was able to achieve a 300% increase in yield with the same amount of energy usage.

    Butler described the concept of “retro-commissioning,” which involves assessing whether an existing facility is operating according to its design and intended use and identifying potential areas for improvement to optimize performance. This can result in typical energy savings of 5–20%, with a payback of less than two years.

    Life Technologies’ internal energy-efficiency efforts will save the company a projected $25 million between 2004 and 2012, reported Cristina Amorim, vp of global EHS and citizenship.

    Little things add up, and big savings can come from unexpected places. For example, historically Life Technologies had shipped its Applied Biosystems TaqMan® assays to customers in Styrofoam coolers. Looking for ways to reduce waste, the company performed stability tests and determined that the reagents could safely be shipped in regular packaging, eliminating the use of 100,000 coolers per year and saving the company $1.5 million/year.

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