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The Chao Center and the fight against multi drug-resistant tuberculosis

Purdue University

The Chao Center for Industrial Pharmacy & Contract Manufacturing (The Chao Center) exists because of the generosity of Purdue alumni Allen and Lee Hwa Chao, who envisioned a fully-regulated pharmaceutical manufacturing facility to train pharmacy students in current Good Manufacturing Practices (cGMP). Purdue University is actively involved in the fight against multi drug-resistant tuberculosis (MDR-TB). Ownership of the drug Seromycin® and its trademark was transferred from Eli Lilly and Company to The Chao Center in December of 2007.

The Chao Center is now the sole authorized manufacturer of this drug in Canada, the United States, and U.S. Territories, including Puerto Rico, Guam, and the U.S. Virgin Islands. Students from Purdue University serve as interns or perform their pharmacy clerkships at The Chao Center and have participated in the manufacture of this life-saving drug.

Seromycin® is an old drug, discovered in 1952 during the ‘golden age of antibiotics.’ The first scientific paper describing efficacy of cycloserine for the treatment of tuberculosis was authored by Henry Welch of the FDA, who headed the entire antibiotic initiative at that regulatory agency in the 1950’s and was the first editor and a co-founder of the journal ‘Antibiotics & Chemtherapy’, along with Selman Waksman of Rutgers, Sir Alexander Fleming, Sir Howard Florey, Dr. H. Corwin Hinshaw, and other giants in science and medicine. See A Brief History of Tuberculosis.

Cycloserine is yet another fruit from the rich harvest of antibiotics produced by Streptomyces. Although it is technically a broad-spectrum antibiotic, its narrow therapeutic index resulted in restrictions being imposed on its use. From the beginning, cycloserine was approved for only two indications: treatment of drug-resistant tuberculosis and mycobacterial infections, and treatment of unresolved urinary tract infections (especially by Enterobacter species and E. coli) that were not responsive to other treatments. These restrictions also limited its market potential. The overall incidence of tuberculosis, and MDR-TB, in North America is small compared to the rest of the world. The incidence is often linked with immigrants who arrive from countries where the disease incidence is much higher. Eli Lilly faithfully maintained this drug for 56 years, but eventually sought a partner to take over the manufacturing and distribution and keep it available for the treatment of MDR-TB. The combination of the manufacturing expertise and educational mission of The Chao Center made it an appropriate candidate for this task.