Israeli biomanufacturer Scinai expands into US with CDMO subsidiary

Biopharmaceutical firm Scinai Immunotherapeutics announced the establishment of its US subsidiary Scinai Bioservices, which will offer contract development and manufacturing organization (CDMO) services to partners in the country.

Amir Reichman, CEO of Scinai, said the company signed a contract with Virginia-based biopharmaceutical company Serpin Pharma to support its clinical manufacturing. “I believe that our expanded presence in the US will significantly enhance the prospects of our CDMO unit.”

Reichman confirmed with BioProcess Insider that small-scale manufacturing in the near term will continue to take place in Jerusalem, Israel. Scinai will also work with third-party suppliers in Israel, the US, and Europe for activities requiring specialized equipment.

“Scinai BioServices is a CDMO specializing in early-stage drug development projects,” Reichman told us. “We focus on process development and optimization, analytical methods development, and small-batch production at GMP or non-GMP grade for clinical or preclinical studies.”

Scinai’s facility is designed to support early-stage biotech startup companies and includes 20,000 square feet of clean room and laboratory space for producing biotechnology-driven products. The firm specializes in bacteria and yeast-based fermentation-generated proteins.

In further establishing its brand in the US, Reichman said that Scinai’s “strategy includes hiring sales representatives, increasing attendance at US-based biotech conferences, and creating brand awareness and relationships with local biotech companies in the US."

"The next step would be to buy or build our own facility in the US.”

Scinai cited its US presence as a way for small companies to counteract the effects of the BIOSECURE Act, should it become passed into law. The much-discussed Act would prevent certain named Chinese companies such as WuXi Apptec and WuXi Biologics from receiving grant funding from the US government, which could in turn have major implications on the biopharmaceutical supply chain in the country.

Reichman said that such a law creates potential issues for small biotech companies. “These startups, which receive US governmental grants, might be prevented from contracting with Chinese CDMOs and using US grant money to pay for their services." He added, “This restriction could further constrain the capacity available for their projects. Considering that large pharmaceutical companies will likely book the majority of the lines with well-known, eligible CDMOs, it is reasonable to assume that small biotech startups could face longer wait times for available capacity with eligible CDMOs.”