We are working to better understand the qualitative and quantitative impacts of our products and recognize that employees across Bristol-Myers Squibb have a role to play. Our management system requires business functional areas to identify, evaluate and minimize the direct and indirect EHS impacts of existing and newly developed product lines.
Polyvinyl Chloride Use
Stakeholders have been urging companies to eliminate polyvinyl chloride (PVC) from plastic products and in packaging because of potential health concerns. As part of Bristol-Myers Squibb’s commitment to developing and manufacturing more sustainable products, we have made significant progress to reduce PVC from our packaging components. We are continuing to explore opportunities to eliminate PVC as technical alternatives become available.
To date, we have eliminated PVC from our rigid packaging containers (bottles), reduced the use of PVC in blister packaging for medicines and have eliminated the use of PVC packaging trays. For all new products requiring a blister package, Bristol-Myers Squibb is committed to evaluating alternative materials that will not only replace PVC, but be environmentally friendly.
We have also found vendors who do not use PVC in the standard plastic bottles to package pills and have moved away from PVC secondary packaging in physician samples.
Product Life Cycle Responsibility
For many years, Bristol-Myers Squibb has reviewed and worked to reduce the EHS impacts of our products throughout their life cycle from design and development through manufacturing, distribution, sales, use and ultimate fate. Our product life cycle (PLC) reviews of products continue to produce EHS and economic benefits at our operations around the world. Company initiatives that support PLC responsibility include sharing technical expertise with others.
Our packaging group is developing metrics for environmental improvements, engaging with customers to identify potential packaging improvements and setting goals each year for specific sustainability-related packaging projects.
Bristol-Myers Squibb engineers incorporate sustainable packaging design principles into their day-to-day responsibilities. For example, engineers redesigned cold chain shippers to improve efficiency and reduce packaging weight. As a result of these improvements, implemented in September 2008, we reduced the weight of the general overnight shipper used for the ORENCIA® (abatacept) overnight shipper by 20 percent; the ERBITUX® (cetuximab) weekend shipper by 41 percent; and the general overnight shipper used for ERBITUX and other oncological products by 62 percent.
To further reduce the impacts of ORENCIA packaging we developed stability data to support eliminating the exterior paperboard carton. With the U.S. FDA approval in 2009, the new design will now be saving over 33 tons of paperboard annually.
As part of our PLC responsibility, our Green Chemistry program provides scientists and engineers with a tool—the Process Greenness Scorecard—to identify the environmental, health and safety implications of new and existing products and processes. By implementing Bristol-Myers Squibb’s green chemistry principles in the manufacturing process, we are reducing energy consumption, hazardous materials use and waste generation.
The AVAPRO Greenness Project is part of the manufacturing process of a compound used to treat hypertension and renal disease in Type 2 diabetes. We recently started recycling the primary chlorinated solvent used in the bromination step during synthesis of AVAPRO. We eliminated the aqueous extraction step and reduced the amount of crystallization solvent required. These changes have increased the yield of AVAPRO while reducing waste and increasing workplace health and safety. Other benefits of the modified process include a 325-ton reduction in solid waste that previously required incineration and energy savings of 24,400 MW as a result of recycling the two remaining process solvents.
Bristol-Myers Squibb has been working on the Paclitaxel Greenness Project during the manufacturing process of the anticancer drug, TAXOL. Recently, we switched production to the latest Plant Cell Fermentation (PCF) technology, which has improved the sustainability of the supply of paclitaxel while reducing the amount of waste and pollutants, as well as reducing the risk from occupational exposure. Through the application of the PCF technology, paclitaxel is being made using only plant cell cultures.
The National Cancer Institute selected Bristol-Myers Squibb to be the commercial developer of TAXOL in 1991. At that time, the drug was manufactured from the bark of a yew tree found in the U.S. Pacific Northwest and the projected demand for TAXOL far exceeded the potential supply available from tree bark. Bristol-Myers Squibb was also concerned about supply dependability and consistency, and felt compelled to find an alternative source of paclitaxel for commercial production. Under the agreement with the National Cancer Institute, we pledged to develop a more environmentally sustainable supply of paclitaxel within five to eight years and managed to meet this goal in half the time.
In 1994, we received U.S. approval for a new process to manufacture the drug from cultivated yew shrub twigs and needles. Cells are extracted from yew tree twigs and needles, which are then reproduced to create TAXOL. This method improves the consistency and quality of the raw material. Also, by using twigs and needles from shrubs instead of bark as the source, trees are unharmed when harvesting the raw material. This protects the yew tree and also greatly increases the long-term supply of available raw material. The new process requires less raw material than the original process and the habitat of the spotted owl is not compromised.
Through eco-efficiency, we are improving productivity while reducing negative environmental impacts. For example, innovation teams working at Swords, Ireland, have successfully achieved yield improvements, ranging from 1.5 to 4 percent, in seven products or intermediates, resulting in increased efficiency and reduced waste. The solvent recovery plant at the Swords facility allows the on-site recovery of nearly all the solvents rather than off-site removal. The recovered solvents can then be reused on site, leading to reductions in fresh solvent purchasing requirements. In 2008 and 2009, Swords recovered 1,075,000 and 830,000 tonnes of solvents, respectively.
Biotechnology and Biosafety
Bristol-Myers Squibb has established specific requirements for biological safety, security and containment at its facilities worldwide. The company's biological safety requirements are based on the U.S. National Institutes of Health Guidelines and the World Health Organization (WHO) Biosafety and Biosecurity Guidelines.
Bristol-Myers Squibb has established a Corporate Biological Safety Directive to address biosafety, biosecurity and bioethical issues associated with our work with biological agents and other biological materials, including genetically-engineered/modified organisms and development processes. In addition, BMS has implemented a biological assessment of risk process to facilitate risk assessment, management/control and communication of our use of biological agents and materials. BMS employs trained Biosafety Officers and has established Institutional Biosafety Committees to oversee risk assessment/management systems. Through a robust self-assessment process, facility, business unit and corporate staff regularly monitor biological safety program effectiveness and seek to continuously improve our biosafety program.
At the R&D level, each R&D facility has a qualified Biological Safety Officer to ensure that systems are in place for biological safety, containment, and security. An Institutional Biosafety Committee (IBC), with at least two independent members from the local community, oversees all research at the facility involving biological agents or genetically modified organisms and assures a thorough risk assessment of each project. They also serve to provide a public forum for addressing local stakeholders’ biotechnology questions and concerns about genetically modified organisms, including research involving recombinant DNA.
At the manufacturing level, a qualified Biological Safety Officer is also responsible for ensuring that systems are in place for biological safety, containment, and security. A Biotechnology Transfer Assessment process ensures that the risk assessment developed by R&D accompanies each process transferred to the manufacturing level. As part of this risk assessment process, Bristol-Myers Squibb assigns a risk category to each biological process. These categories are consistent with those used by the U.S. Centers for Disease Control and Prevention, the U.S. National Institutes of Health, and the WHO. Containment technology, including engineering and facility controls, safety equipment and work practices, are established and implemented for each risk category.
All Bristol-Myers Squibb facilities utilize stringent containment methodologies and all bioprocess wastes are treated and deactivated before leaving a Bristol-Myers Squibb facility.
Bristol-Myers Squibb has developed an innovative Web-based Biological Risk Assessment management system. The system provides facility biosafety officers with comprehensive and detailed information about potentially biohazardous research projects being conducted within the company.
Commitment to the Ethical Use of Animals in Research
At Bristol-Myers Squibb our mission is to discover, develop and deliver innovative medicines to patients with serious diseases such as cancer, diabetes, hepatitis, HIV/AIDS, cardiovascular disease, and immune-system disorders like rheumatoid arthritis. We have both a legal and an ethical obligation to ensure the safety and efficacy of investigational medicines. Regulatory agencies around the world, including the U.S. Food and Drug Administration, require that investigational medicines be thoroughly evaluated before approving them for use in human clinical trials. To fulfill these obligations, research or testing methods that include the use of animals are sometimes required, and will continue to be a component of our efforts to help patients prevail over serious diseases.
At the same time, we are committed to reducing our reliance on animal testing methods, and promoting the development, validation and use of non-animal testing models. The company confers an annual Animal Welfare Award to scientists who have implemented innovative scientific methods or procedures that reduce the number of animals required in research while still obtaining valid results, refine research methods to eliminate or minimize impact to animals, or replace animal use in testing. Over the past two decades Bristol-Myers Squibb has moved to a research system that relies on a combination of in silico, in vitro and in vivo approaches.
For example, Bristol-Myers Squibb has created a world-class imaging department that has allowed scientists to view the impact of experimental drugs on disease and assess the long-term effectiveness of a potential new treatment in a non-invasive manner. In addition, we have provided more than $1 million in funding to other organizations to support the development of alternatives to animal research.
When the use of animals is necessary, Bristol-Myers Squibb is committed to providing the highest level of care. We ensure that the care and use of all laboratory animals meets or exceeds relevant local, national and international regulations, as well as our own internal standards of animal care.
- Bristol-Myers Squibb’s research sites voluntarily seek and secure review and accreditation by an independent organization called the Association for the Assessment and Accreditation of Laboratory Care International (AAALAC), a private, nonprofit organization that promotes humane treatment of animals in science and is internationally recognized as the gold standard for research programs.
- The company’s Animal Care and Use Committees review, approve and monitor all animal use, and perform monitoring audits, as well as semiannual facility animal care and use inspections and program reviews, to ensure the animals are healthy and cared for appropriately.
- We ensure quality veterinary care is available at all times.
- We provide special training and development to all employees who work in any aspect of our animal research programs to ensure they demonstrate ethical and humane care and respect for all research animals. Safe and compassionate procedures for handling and caring for animals are in place at our facilities and disciplinary actions up to and including termination, can be taken against employees who do not comply with our standards and procedures.
- Contractors who carry out research for Bristol-Myers Squibb are also expected to apply the same care and ethical standards, and accreditation requirements. We conduct an Animal Welfare Risk Assessment of contractors and regular inspections to ensure this is the case.