Editor's Note: When this report was posted on TradelineInc.com on February 2, 2006, questions were raised concerning the facility's BSL-1 designation and the use of the word "prototype" in describing the air filtration system.

The Novo Nordisk spokesperson uses BSL-1 here to indicate that per the definition from the CDC/NIH BMBL 4TH Ed., "the work conducted in this facility only involves well-characterized agents not known to consistently cause disease in healthy adult humans, and of minimal potential hazard to laboratory personnel and the environment."

At the time the report was written, the air filtration system described was still considered a prototype. The system is now commercially available from the vendor that developed the customized system for Novo Nordisk. For more information about the filtration system, please contact Jan Ottesen, Director of the Animal Unit, Novo Nordisk.

 

Novo Nordisk is a world leader in diabetes care, featuring the most diverse diabetes product portfolio in the industry. It also has a leading position in haemostasis management, growth hormone therapy, and hormone replacement therapy. Based in Copenhagen, Novo Nordisk employs approximately 20,600 full-time employees in 78 countries. The company operates under the philosophy of the triple-bottom-line, where success is measured in terms of economic, social, and environmental performance.

"We have to integrate environmental and bioethical considerations into our business, along with economical ones. It's not a matter of whether our employees think this is a good idea, it is an upper management decision from the company," says Jan Ottesen director of Novo Nordisk's animal unit.

The new facility, a small-animal BSL-1 research lab built at the company's main R&D site in the Copehnhagen area, showcases Novo Nordisk's commitment to proactive bioethical responsibility. In all cases, the lab meets or exceeds mandated European standards for animal treatment, habitat, researcher safety, and environmental impact.

"We believe that focusing on more than just the economic bottom line is good business. If you look at the Dow Jones sustainability index you will see that the companies following these rules are doing better than the companies that are not," says Ottesen.

Clear Goals, Modern Designs

Based on an existing master site plan, the project called for a single three-story vivarium facility to house in vivo and in vitro lab space, with offices for 150 researchers. Novo Nordisk hired its subsidiary NNE—a leading supplier of engineering services to the international pharmaceutical and biotech industry—to design and build the lab.

NNE created an interdisciplinary design team consisting of architects, engineers, animal technicians, laboratory technicians, health and safety organizations, and animal ethics groups, who all participated in project planning from conceptual design to final hand over.

"A high level of involvement early on in the process by the client and project stakeholders was essential to our success," says Flemming Nielsen, an NNE design engineer and architect.

The project team collaborated to create a state-of-the-art animal research facility with unprecedented focus on flexibility, animal welfare, researcher safety, and security.

"We wanted input from everyone involved to make sure potential problems were identified and solved early in the process, and to build the best facility we could," says Nielsen.

Proactive Collaboration

As part of the workshop process, Novo Nordisk and the Danish animal welfare society worked together to develop a common understanding of good animal welfare and to identify areas for improvement. Internationally recognized animal welfare experts were invited for several workshops to establish the most important needs of the animals in their natural habitat. Based on the results of these workshops, new caging prototypes were developed which take into consideration the needs of animals to a much greater degree than ever before.

Adapted recommendations include the need for mice, rats, guinea-pigs, and rabbits to have a diverse and free range of motion, including the ability to rear up on their hind legs. It is also important for these animals to have social contact, ideally housed together in connected cages. To accommodate these needs and the safety needs of researchers, Novo Nordisk together with a local supplier developed custom prototype cages with higher ceiling heights and three-dimensional interaction areas. This new caging system was subsequently integrated into the building design and includes modular automated watering and filtration to increase flexibility.

Another progressive design feature is the implementation of a music system in all animal rooms and four channel options.

"Beyond ensuring better welfare of the animals, the new systems are much more pleasant and contribute to a broader acceptance by the public of experimental animal use," says Ottesen.

Bioethics of Architecture

Some of the facility's key bioethical design features include natural daylight via windows and skylights for all permanent work and animal areas, a significant emphasis on safety, and the use of green and local alternative building materials wherever possible.

Workflow and airflow are key elements of the facility’s enhanced safety and security design. The only way into the vivarium barrier is through the basement, which features employee lockers, air showers, and double-door airlocks.

The main floor houses in vivo laboratories, animal holding rooms, cage wash facilities, and support services. The second floor contains open office space and in vitro laboratories. Researchers pass between levels via an elevator and stairs, both integrated within the barrier.

Rooms are laid out in a double corridor design that allows for low-impact workflow.

In vivo laboratories are placed as close to the animal holding rooms as possible to minimize disruption, and in vitro labs are connected to the vivarium through an airlock that allows organs and samples to enter without allergenic exposure.

"We programmed the facility's workflow to reduce the transport of live animals, with the goal of reducing animal stress and increasing worker safety," says Ottesen.

To maximize flexibility, NNE designed the vivarium around a modular suite layout. Animal holding rooms are organized into suites that allow a change in configuration from two large rooms to four small rooms, each connected directly to a procedure room.

The adjacent procedure room allows sample work to be done without moving the animals into the laboratories. Additionally, each suite can be individually controlled with reverse daytime rhythms.

The in vivo labs are equipped with parking stations so it is possible to bring rack systems into the lab, hook them up to the ventilation and watering system, and allow animals to stay comfortably in the labs overnight for longer term experiments.

Other environmental enhancements include a roof-top garden above the vivarium, full-length skylighting over the main access corridor, and artwork by local artists.

Innovative Airflow

Protecting researchers from allergen exposure was also a significant project goal. Allergen exposure was reduced by focusing on the facility's airflow. In addition to outfitting the access point with air showers, NNE developed a specialized surgery table with controlled airflow functions that protect researchers from allergens during all operations.

A custom air filtration system was designed for the building to accommodate the new cage racks. The system, which is now commercially available through the vendor that developed it for Novo Nordisk, provides a clean work surface area and allows workers to easily change air filters via ceiling access panels.

Lessons Learned

One of the most important things the design team learned was that end-user workshops and a focused collaborative approach to design were essential to the project's success.

"We did a lot of workshops throughout the entire design process, and they really helped eliminate mistakes and prevent them from becoming project changes," says Nielsen.

Allocating enough time for this level of planning and development was also critical.

"In the end, we could have used even more time for the collaboration and planning process. It's safe to estimate your time allocation and multiply that by two," Ottesen says.

On this note, both Ottesen and Nielsen agree that it is important to take the time to fully test all prototype designs extensively with end users prior to implementation.

Ottesen also emphasizes the importance of allocating more than one key person for each user group on the design team, and making the position a full-time job.

Innovative materials and design approaches also proved essential to the project's success.

"A big part of getting this project to succeed from a human welfare standpoint was seeking out innovative design solutions, and using alternative construction materials. These details bring an increased level of humanity to the facility," says Nielsen.

By Johnathon Allen

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