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news.The BioBalance Corporation, a subsidiary of New York Health Care Inc, has entered into a manufacturing and supply agreement with Benchmark Biolabs for the gastrointestinal disorders drug, Probactrix.
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Under the agreement, Benchmark will manufacture Probactrix for BioBalance’s proposed clinical trials in the US once BioBalance receives FDA clearance to proceed with those trials. The product will be manufactured in a state-of-the-art facility located in Lincoln, Nebraska.
Probactrix is a proprietary, live strain of E coli M-17 that is being developed as a prescription biological drug for the treatment of pouchitis and other gastrointestinal (GI) disorders.
In order for BioBalance to achieve regulatory approval of Probactrix, among other things, the FDA will ultimately require that Probactrix be manufactured in a facility certified under good manufacturing procedures (GMP). It is anticipated that Benchmark’s manufacturing facility will become GMP-certified in the future.
“We are pleased to have selected Benchmark as our contract manufacturer for our lead therapeutic product candidate,” said BioBalance’s CEO, Dennis O’Donnell. “This agreement is key to ensuring a consistent and high-quality supply of Probactrix for our proposed clinical trials.”