Product Stewardship
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.
Green Chemistry
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.
AVAPRO® (irbesartan)
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.
TAXOL® (paclitaxel)
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.
Eco-Efficiency
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.
Animal Testing
For over a century, Bristol-Myers Squibb and its predecessor companies have been committed to providing safe and effective quality products. This commitment, at times, requires the responsible care and use of animals for research or testing. Animal studies provide essential information, not available through other methods, about the affects of new therapies on disease and the patient. Regulatory authorities around the world, including the U.S. Food and Drug Administration, require safety data from animals before a new medicine can be tested in human clinical trials. As part of this process, we are committed to the highest standards of humane care and treatment of our laboratory animals.
It is the policy of the company to insist that our scientists always consider replacing the use of animals by other methods, reducing the number of animals used and refining procedures to enhance animal welfare (also known as the 3Rs – replace, reduce and refine). Bristol-Myers Squibb is committed to developing non-animal tests, and using them whenever possible. The company confers an annual Animal Welfare Award to scientists who have implemented new procedures that reduce, refine or replace animals used in our studies. We have supported development of alternatives to animal research both internally, as part of the discovery and development process, and externally with over one million dollars of funding to other institutions
To ensure the humane treatment of laboratory animals, when their use is appropriate, it is our goal that all laboratory animal facilities, internal and contracted, be accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International, an unaffiliated review organization. Loss of accreditation may result in the termination of contracts. In addition, all Bristol-Myers Squibb facilities and programs involved with the care and use of animals are periodically subjected to rigorous inspections by company auditors and government inspectors.
Any procedures at Bristol-Myers Squibb involving the care and use of animals must comply with applicable governmental regulations, a review to consider non-animal alternatives and corporate animal care and use directives. Animal Care and Use Committees are charged with reviewing and monitoring these procedures and each internal, external or contracted animal study protocol generated by any Bristol-Myers Squibb employee to ensure that animals are cared for and treated humanely and meet our high standards. The committees also perform semi-annual facility inspections and program reviews to ensure that the animals are healthy and cared for appropriately.
Our contractors must apply the same rigor to their animal care and use programs that our own facilities do. We evaluate each contractor animal care and use program (including commercial laboratories, academic institutions, veterinary practices, farms and other animal care and use agencies or facilities) for conformance to published regulations and standards for the humane care, treatment and use of all animals.
Appropriate training for each of our scientists, animal care staff and committee members is orchestrated through the department of Veterinary Sciences. Employees involved in any aspect of our animal research program attend regular training that addresses humane care, use and respect for all research animals. We use new employee orientation, computer-based training and hands-on training to ensure best practices and proficiency.
Bristol-Myers Squibb believes our pursuit of quality humane care, reduced use of animals and the development of alternatives to animal use are moral, scientific and legal necessities. The commitment to animal welfare detailed in Bristol-Myers Squibb policy, drives our employees to ensure that all animals used for essential research and testing at the company are treated in a caring and humane manner.