Growing biomed firm rolls with the changes: Under string of owners, Seradyn develops niche producing immunoassays

January 21, 2008

Life sciences firm Seradyn Inc. on Georgetown Road has endured a revolving door of owners in the 30-some years since its inception. But what hasn't changed is its dedication to developing immunoassays for medical purposes.

Immunoassays are chemical tests used to detect or quantify a specific substance-the analyte-in a blood or body fluid sample.

Seradyn develops and manufactures assays that use antibodies to measure drug concentrations in the bloodstream. In the past 10 years, Seradyn has developed 15 such products used in the management of epilepsy, transplantation and infection.

Most recently, in October, it became the first company to introduce assays that measure the concentrations of antiepileptic drugs lamotrigine and zonisanide. The two are newer epilepsy pharmaceuticals that have proven effective in controlling seizures.

While several companies produce assays for older drugs, Seradyn is among the few developing assays for the newer anti-epileptic drugs. That's because larger diagnostic companies focus more on drugs that serve a larger segment of the population. It is estimated that 2 million to 2.4 million people in the United States are afflicted with epilepsy.

Yet, Seradyn has great potential, said C.E. Pippenger, a clinical pharmacologist and adjunct professor at the University of Vermont's Pharmacology Department.

"Not only do they have great scientists, but they have a great ability to work with the scientific community on both the manufacturing and clinical sides of the fence," he said.

The anti-epileptic drugs, combined with others that have no assays, present tremendous opportunities, Pippenger said. Chemotherapy drugs, as well as antidepressant and anti-psychotic medications, are examples for which no assays are available.

For Seradyn, an expanded product line could be in the offing, company General Manager Mark Roberts said.

"We look for drugs that we think need to be monitored," he said. "It's a very important tool for the physician."

The latest in a string of acquisitions involving Seradyn's parent should give the company more resources to grow. Roberts said the company has plans to expand the 55,000 square feet it occupies on the northwest side of Indianapolis and grow the number of employees from the current 130. Even so, that's good enough to rank Seradyn as the sixth-largest biotechnology and pharmaceutical firm in the area, according to IBJ statistics (see list on page 23).

String of acquisitions

In November 2006, Massachusettsbased Thermo Electron Corp. purchased Seradyn's parent company, New Hampshire-based Fisher Scientific International Inc. The $10.6 billion stock deal created Thermo Fisher Scientific and, with $9.2 billion in combined revenue, a giant in the field of laboratory equipment.

Roberts declined to divulge annual revenue for Seradyn, but said each merger it has gone through in the past has led to more growth.

Seradyn's roots date to the mid-1970s when the former Dow Chemical Co. established the Dow Diagnostics division to produce clinical assays.

Dow Chemical sold its diagnostics division in 1983 to Boston-based technology company Seragen Inc. Seragen, however, divested the business in 1986, establishing the Seradyn name.

The company operated independently for three years until Mitsubishi Chemical Co. acquired it. In 1998, Mitsubishi sold Seradyn to Wisconsin-based Sybron International Corp., which began conducting business in 2000 as Apogent Technologies.

In 2004, Apogent merged with Fisher Scientific, which was acquired by Thermo Electron Corp. two years later, bringing Seradyn's complex history up to date. Through it all, there's a reason companies like Seradyn that are operated by outside ownership remain in Indianapolis, BioCrossroads Director David Johnson said.

"They don't get moved because the right people who work in them already live here," he said.

Supporting player

But don't expect Seradyn's name to become widely known. It contracts to manufacture products under the names of large pharmaceutical and diagnostic companies to maximize distribution channels.

For instance, it collaborated with Switzerland-based Novartis to develop an assay for Novartis' immunosuppressant drug Certican.

Pippenger at the University of Vermont said Seradyn has effectively built partnerships in an industry in which that task can be difficult. Drug manufacturers historically had been apprehensive to have their drugs monitored, Pippenger said, because of the potential for additional costs and the fear they might be viewed as unsafe.

Seradyn and its assays are critical to the local life sciences initiative BioCrossroads is leading, Johnson said. This fall, BioCrossroads launched an initiative called Linx. Part of its goal, Johnson said, is to connect big drugmakers to smaller research firms and others that help drugmakers test, develop, produce and deliver new drugs.

"We have a very, very active life sciences new-discovery sector here that is supported by a whole lot of companies that have grown up to get drugs discovered and get to the marketplace," he said. "[Seradyn] really is part of the whole supporting factor for the sector we have here."

The company spends about three years developing an assay, Roberts said. Its assays use serum or plasma to measure patient drug amounts that are typically monitored when medication is introduced, when there's a change in dosage, or when the patient's condition changes. Higher dosages can create adverse effects while smaller ones might not treat the illness effectively.

Monitoring in the 1960s took as long as two days and originated with anti-epileptic drugs. Now the process takes minutes. Epileptic seizures often can result in injury, underscoring the importance of drug management, said Jim Cloyd, chairman of the Department of Orphan Drug Development at the University of Minnesota's College of Pharmacy.

"It's particularly useful in epilepsy, where the condition is unpredictable," he said. "And if the treatment doesn't work and you have another seizure, it can be disastrous."

Another part of Seradyn's business involves designing and manufacturing synthetic polymer microparticles. They are used by leading molecular diagnostic companies as an essential building block of their reactants.

The microparticle technology is the foundation for Seradyn's assays. In fact, 85 percent of the U.S. blood supply is tested by assays that use Seradyn's microparticles.
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