Mark Wicker JASON VARNEY | VARNEYPHOTO.COM

In Greensboro, NC, Mark Wicker runs his own company, Carolina Research Glass, where he produces one-of-a-kind, hand-blown laboratory glass. One of only 600 scientific glass blowers in the country, Wicker works in Pyrex and produces about 500 objects a month. "I make drug- and aerosol-delivery devices, isolation cages for rats, and glass vessels for exposing lung tissue," he explains. He also polishes, grinds, and repairs glass equipment, which is highly cost effective, he says.

Wicker makes up part of a crucial element of biotechnology in North Carolina - companies that provide services or products that keep other companies in business. For pharmaceutical companies in particular, service providers must meet certain levels of quality and reproducibility. It's one thing to develop and market a new hammer, but it's another to develop and market a new cancer biologic made from stem cells.

North Carolina's health-service industry thrives, in part, because biotechnology tends to originate as small, unique companies that aren't equipped to deal with all the complexities, such as regulation and testing, that big pharmaceutical companies accomplish in-house. Instead, smaller organizations, so prevalent in the state, must reach out to other small companies, or to larger consulting groups, to fill in their missing pieces.

"The service companies are so important," says Barry Teater, director of corporate communications at the North Carolina Biotechnology Center. "They help biotechnology survive and drive."

The value chain for biotechnology travels from discovery and product development through manufacturing and on to sales. All along that path, service companies are called in for scientific and business advice, technical assistance, laboratory support, and information processing.

Many biotech companies begin with one scientist who discovered and developed a technology while on the faculty of a university. Unlike nonuniversity-based scientists, these entrepreneurs - once they decide to leave campus and work for profit - must first deal with the proprietary rule of the university. Robert Keefer, managing director of TCG Biopharma, explains how complex this move can be, and how a service company can help. He says that the scientists "need to negotiate the rights to the technology. Likewise, the university wants to be compensated for fostering the development of the technology, which would come down to royalties." Companies such as TCG Biopharma are familiar with this path, and they aid others through the difficult negotiations.

The next stage for any newly formed business is to build a functioning company, a process unknown to many academics. The new company needs a business plan, a CEO to run the company, and an organization that will help the researchers realize their dream. Consulting companies such as the Catevo Group and others help with the business plan. These companies will map out every angle of running a profitable business, from the inception of an idea to marketing, an often eye-opening process for the uninitiated.

During discovery and product development, a fledgling company must also test its product in an atmosphere beyond a small research lab. Included in that part of development is the need to understand and fulfill a complex set of regulatory issues that are in place to protect human health. Cato Research in Durham, Biotechnology Transfer in Raleigh, and others can help with every detail of that process. These companies are experienced in setting up preclinical studies as well as the clinical trials required by the US Food & Drug Administration. They can also expedite any required documentation for drug approval, a process that can take years. Likewise, companies such as Triangle Certification in Durham will tackle certification of clean rooms and filtrations systems and make sure that every step of the process follows industry and federal standards.

Once a company is developing a technology for a public market, it must decide how to manufacture the product at a larger capacity and cost-effective rate. Moreover, the product must be made without altering consistency or quality. Many biotech companies end up purchasing, rather than making, some of their mediums, stains, or other lab products from highly specialized health-service companies. For example, Zen-Bio is what its president, Peter Pieraccini, calls a "tool company for other companies" because it isolates human fat cells and repackages them for sale. Adipose cells are currently used in research, development, and manufacturing aimed at metabolic diseases and conditions such as diabetes and obesity. The HIV virus also harbors in fat cells so adipose cells are important for viral work as well.

Moving toward manufacturing might also mean reengineering a production line as it expands, as Avid Solutions in Winston-Salem and Raleigh might advise. A production line might also include an automation system, which could be designed by BioMachines in Research Triangle Park.

Before production begins in earnest, companies also need to test their process for safety. Laboratory safety standards are there to protect technicians and ensure that the product is manufactured consistently. Companies such as Flow Sciences in Leland can help with that goal. This company invented the Vented Balance Safety Exchanger that is designed for use with powered substances. Unlike a typical fume hood that is used when working with solvents, Flow Sciences' hood helps with mixing, measuring, and packaging pharmaceuticals. "Ninety percent of our business is pharmaceutical and 10% is cellular, but that market is growing," says Stephen Janz, vice president for marketing and business development at Flow Sciences.

Keeping a lab working also depends on people who are experienced in performing specialized jobs. "We cover everything that's in the lab," says Roy Marshburn, president and CEO of Spectrofuge, a laboratory equipment-repair company based in Durham. "We work on refrigeration, analytical equipment, and very high-tech equipment," Marshburn explains.

Robert Keefer JASON VARNEY | VARNEYPHOTO.COM

All along the way, a company needs information, most of which cannot be found with a search on Google. All biotech and biopharma companies - including established companies with new products in development as well as those starting out - need to know everything about competitors and the market. Mark Dibner, president of Bioability, explains that his service company is staffed with PhDs and MAs in the life sciences, people who know how to ferret out information. "A lot of companies are just starting out or are not large enough, and they can't afford to have an information specialist in-house and buy into the various data bases you might want to have to run your company, and yet information is vital to strategic planning," Dibner says. Service providers can often collect in-depth data more efficiently, economically, and completely than most companies can collect on their own. Companies such as Bioability can also help write well-informed business and strategy plans.

Consulting groups are also important because a company needs to commercialize its product right from the beginning. "It's all part of brand management, how you build a brand," points out Keefer. "You are doing everything you can to build a brand in the image of the patients and the doctors and the health insurers, the reimbursement people." In other words, the company needs to educate physicians and the public and make sure that product becomes well known and trusted. Branding, then, is not just coming up with a catchy name, but building a product outside the laboratory even before the product enters the marketplace.

At the end of the value chain, a staff of marketers and sales people take a product from a lab bench to consumers by using media advertisement, conventions, and one-to-one visits to doctor's offices. Some smaller firms elect to sell their product to bigger companies that have extensive marketing and sales departments. Other companies might rely on the same consultants who helped them write their business plan in the first place. Still others will hire companies such as TCG Biopharma to figure out how to best market their product on their own.

Many of the companies that service North Carolina's biotech and pharmaceutical sector no longer stay within state lines. Indeed, most of these companies lend a hand to similar health companies across the United States. More interesting, their business now crosses oceans and continents. For example, Flow Sciences makes containment devices that get exported to laboratories in Europe. The North Carolina biotechnology and pharmaceutical business has grown exponentially, and so it is only natural that those industries bring North Carolina to the larger world.