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THE BIZ
PERSONNEL PROFILE
Quality Control KRS Global keeps pharmaceuticals clean under Riccardo Roscetti's watchful eye Written by GARY GREENBERG
R We scrutinize everything. At eight o'clock in the morning, I'm in the lab looking at samples, checking the environmental monitoring, making sure we have no bacterial growth ... in our clean rooms.” —Riccardo Roscetti
bocamag.com
Biz MARCH17.indd 68
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iccardo Roscetti is a bit of a clean freak. But he has a good excuse. Roscetti runs KRS Global, a biotech company that produces sterile pharmaceutical products. “We scrutinize everything,” said Roscetti, a self-confessed “lab rat”and CEO of the Boca Raton-based company. “At eight o’clock every morning, I’m in the lab looking at the samples and checking the environmental monitoring, making sure we have no bacterial growth, or anything like that, in our clean rooms.” KRS currently has eight high-tech clean rooms where lab workers clad in protective gear from sole to scalp formulate the injectable medications in a pressurized environment kept pristine by high-efficiency particle (HEPA) air filters. There are redundant safeguards and continual monitoring of air quality as well as drug purity and dosage. Still, problems can arise. Roscetti once had to toss $30,000 worth of a drug because the pH was too acidic, and he says it may have stung the patients during injection. A bigger threat is contamination by bacteria
or fungi, which can be deadly. “We’ve never had a recall because I’d rather throw it away if there’s any uncertainty about it potentially hurting someone,”he said. KRS was founded in 2001 by Boynton Beach resident Roscetti, 53, and his partners Ken Johnson and Shane Brown. The company produces generic drugs as well as IV bags, syringes and other products for clients including pharmacies, hospitals, doctors’ offices, universities and veterinary clinics. Most of the business these days comes from filling drug shortages. “If a drug is not available because the pharmaceutical companies didn’t make enough, compounders like us fill that need,”he said.“The FDA keeps a shortage list, and we produce many of those drugs.” Business is booming, and Roscetti said plans are in the works to double the size of the facility and increase the staff from 100 to 160 by the end of 2017. “Boca is a great spot for us,”said Roscetti. “Between city support and the talent coming out of FAU, it’s a great environment for a biotech company.”
March 2017
1/30/17 5:04 PM