Scinai Immunotherapeutics Forms CDMO Subsidiary in US

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On Dec. 16, 2024, Scinai Immunotherapeutics (Scinai), an Israel-based biopharmaceutical company focused on developing inflammation and immunology biological products, announced that it has established a US-based subsidiary for its contract development and manufacturing organization (CDMO) services. The company provides CDMO services through its Scinai Bioservices business unit. The new US subsidiary will operate under the name Scinai Bioservices Inc. and will be incorporated in Delaware.

The Scinai Bioservices CDMO business unit was launched in 2024 and operates from the company's site in Jerusalem, Israel. The Jerusalem facility comprises 1850 square meters (approximately 20,000 square feet) of clean rooms and laboratories, which operate under current good manufacturing practice (CGMP) conditions in compliance with European Medicines Agency (EMA) and FDA requirements, according to a company press release (1).

"We are thrilled and energized by the opening of our new subsidiary in the [United States]. Last week, we signed our first contract with US customer, Serpin Pharma, to support their clinical manufacturing,” said Amir Reichman, CEO of Scinai, in the press release (1). “I believe that our expanded presence in the US will significantly enhance the prospects of our CDMO unit."

From its launch, the CDMO unit has executed drug development projects for nine different biotech companies, which included upstream and downstream process development, scale-up, analytical methods development, and drug manufacturing for pre-clinical and clinical supplies. The company has also partnered with Ayana Pharma, an Israel-based pharmaceutical company specializing in liposomal therapeutics for treating cancer, under which Scinai will provide liposomal encapsulated drug development services.

The Scinai Bioservices unit operates on projects at the early stage, where the company noted in its press release capacity is strained because of the complex manufacturing processes associated with biologics. “Additionally, the BIOSECURE Act, introduced in January 2024, aims to prevent ‘foreign adversary biotech companies’ from receiving US federal funding,” the company stated in its press release (1).

Scinai's new US subsidiary aims to serve US-based early stage biotech companies with the goal of providing required CDMO services that are currently in short supply. The US subsidiary will also allow early stage biotech startups, which are supported by US government grant funding, to use their grant money in contract with Scinai, which would allow them to avoid concerns related to the BIOSECURE Act, Scinai stated in its press release.

To put the situation into context, Parviz Shamlou, senior vice-president of Science and Technology, Abzena, spoke to the PharmTech Group during BIO 2024 this past June about the impact the act will have on the bio/pharmaceutical industry and how the industry is preparing for it. “We appreciate that [the BIOSECURE Act] is an important act designed to protect the health of citizens of this country. And we know we must do everything we can to avoid any unintended, potentially harmful use of our services as highlighted in the act. [We] have put in place a robust contingency plan as well as a CMC [chemistry, manufacturing, and controls] strategy that are designed to mitigate any such risk to supply chain and the development of the assets that our clients bring to us,” Shamlou stated in the interview (2).

References

1. Scinai Immunotherapeutics. Scinai Immunotherapeutics Establishes US Subsidiary for CDMO Business Unit, Scinai Bioservices Inc. Press Release. Dec. 16, 2024.
2. Haigney, S. BIO 2024: Impact of Biosecure Act on the Pharma Industry. BioPharmInternational.com. June 5, 2024.