Israel-based biopharma company Scinai Immunotherapeutics has announced the creation of a U.S.-based subsidiary for its CDMO business unit, which will operate under the name Scinai Bioservices.
While the demand for biological early-stage drugs is growing in the U.S., Scinai contends that the capacity “may be strained due to the complex manufacturing routes associated with biologics.” Scinai Bioservices will leverage the company’s 20,000-square-foot facility in Jerusalem, Israel, which includes clean rooms and laboratories operating under cGMP conditions in compliance with European Medicines Agency and FDA requirements.
Since the launch of its CDMO business unit earlier this year, Scinai says it has conducted drug development projects for nine biotech companies, including upstream and downstream process development, scale-up, analytical methods development, as well as drug manufacturing for pre-clinical and clinical supplies.
“We signed our first contract with U.S. customer, Serpin Pharma, to support their clinical manufacturing. I believe that our expanded presence in the U.S. will significantly enhance the prospects of our CDMO unit,” Scinai CEO Amir Reichman said in a statement.
According to the announcement, Scinai Bioservices will allow early-stage biotechs — supported by U.S. government grant funding — to “use their grant money by contracting with us, avoiding any concerns related to the BIOSECURE Act.”
However, the BIOSECURE Act, a bill which seeks to prevent U.S. federal funds from supporting certain Chinese contract manufacturers, has hit a legislative roadblock. While it remains unclear if the legislation will become law, non-China-based CDMOs could benefit.