Product Lifecycle

Assessing the Environmental Footprint of Our Packaging

Pharmaceutical and biotechnology packaging is highly regulated, as it is necessary to preserve the product integrity and protect its contents from tampering. Among other things, our packaging is also a source of waste. Incorporating environmental sustainability into our packaging decisions helps us to reduce the amount of materials used and the associated packaging waste, as well as achieve cost efficiencies.

To better determine the environmental impacts of our packaging, in 2011 we commissioned an environmental footprint assessment on two of our leading products in the United States and Europe. We plan to use the results to identify additional opportunities to improve our packaging and reduce our environmental impact.

New Flexible Volume Manufacturing Operation in Research Triangle Park (RTP), N.C.

Traditionally, our therapies are produced in large stainless steel vessels that need to be cleaned after each usage. Typically, each cleaning requires approximately 10,000 liters of water and 700 liters of chemicals. In 2011, we retrofitted a warehouse on our RTP campus to produce clinical products. This disposable hybrid manufacturing facility taps both traditional infrastructure and new disposable technology. The disposable technology utilizes presterilized and precleaned bioprocess bags instead of stainless steel vessels, thus avoiding the need for cleaning and sterilizing between uses. As a result, less water and chemicals are used, and the risk of foreign matter contamination is decreased. Lifecycle assessments comparing disposable technologies such as bioprocess bags to stainless steel vessels have demonstrated reductions in the overall environmental impact when bioprocess bags are used¹. Based on external studies, the new disposable bag system could decrease water use by as much as 90 percent, energy use by 30 percent and greenhouse gases by 25 percent. Although the system may also result in a 10 percent increase in waste, we are currently exploring ways to recycle these bags.

Decreasing Product Lifecycle Impacts in Cambridge

In Cambridge, our Chemical Process Research and Development team developed a highly efficient manufacturing process to make dexpramipexole, the active ingredient in the product candidate that is currently in a Phase 3 clinical trial for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. The process improvements resulted in:

• Maximization of efficiency throughout the manufacturing process, resulting in a 60 percent increase in yield, which allows us to create 60 percent more product with the same amount of inputs; and
• Identification of a robust isolation and purification measure that removes all impurities from the product while also reducing a significant amount of organic solvents and chemicals needed for the production of dexpramipexole.

These changes are expected to save 37,000 liters of water, 29,000 kilograms of chemicals, 50,000 kWh of electricity and 2,000 operator hours per metric ton of dexpramipexole produced.

Managing our Supply Chain for Sustainability

Our commitment to environmental sustainability extends beyond our internal operations to our suppliers, which is why we are engaging with them to drive sustainable business practices. The vast majority of our suppliers are located in the United States and Europe. While this reduces many risks related to our supply chain, we understand the need for and importance of proactively monitoring and managing supplier performance. All of our suppliers are subject to our Code of Business Conduct and must meet rigorous compliance standards for quality and comply with applicable external laws and regulations.

Additionally, as part of the Pharmaceutical Supply Chain Initiative (PSCI), we have worked with other members to help develop the Pharmaceutical Industry Principles for Responsible Supply Chain Management (PSCI Principles), which align with international frameworks and standards, including the United Nations Global Compact and the International Labour Organization (ILO). The PSCI Principles lay out high-level expectations in the areas of ethics, labor, health and safety, the environment, and related management systems.

Biogen Idec supports the vision of the PSCI: that through the application of the principles, better social, economic and environmental outcomes will result for those involved in the pharmaceutical supply chain. As such, we are committed to helping our suppliers build their governance, social and environmental capabilities. Starting in 2012, Biogen Idec will be working with the PSCI as it begins conducting audits of member company suppliers for compliance with the PSCI Principles—including evaluating and addressing broader governance and social issues. Third parties will perform these audits under PSCI direction.

In 2011, we also began developing a supplier self-assessment survey to collect a baseline of our GMP (Good Manufacturing Practices) supply chain vendors. The survey, piloted with a few of our suppliers, includes questions on environmental, health, safety, sustainability and security. We will continue to refine and enhance this tool based on feedback from the initial surveys in 2012.

¹Pietrzykowski et al., “An Environmental Life Cycle Assessment Comparing Single-Use and Conventional Process Technology,” BioPharm International © November 2011 supplement