Scinai Immunotherapeutics Establishes U.S. CDMO Subsidiary
Israeli biopharmaceutical company Scinai Immunotherapeutics has launched a U.S.-based CDMO subsidiary, Scinai Bioservices Inc., in Delaware, following the launch of its CDMO unit at the company's HQ in Jerusalem, Israel last year. CEO Amir Reichman announced the company’s first U.S. contract with Serpin Pharma for clinical manufacturing and expressed optimism about the growth potential of their U.S. presence.
Since its inception, the Jerusalem CDMO unit has executed drug development projects for nine different biotech companies, including upstream and downstream process development, scale-up, analytical methods development and drug manufacturing for pre-clinical and clinical supplies. Additionally, the Company has partnered with Ayana Pharma to provide liposomal encapsulated drug development services.
The following article originally appeared in PR Newswire.
Scinai Immunotherapeutics Ltd, a biopharmaceutical company focused on developing inflammation and immunology (I&I) biological products and providing CDMO services through its Scinai Bioservices business unit, announced today the establishment of a U.S.-based subsidiary for its Contract Development and Manufacturing Services. The new subsidiary, incorporated in Delaware, will operate under the name Scinai Bioservices Inc.
In 2024, Scinai launched its CDMO business unit, branded as Scinai Bioservices, operating from the Company's site in Jerusalem, Israel. This facility includes 1,850 square meters (approximately 20,000 square feet) of clean rooms and laboratories, all operating under cGMP conditions in compliance with European Medicines Agency (EMA) and FDA requirements.
Since its inception, the CDMO unit has executed drug development projects for nine different biotech companies. These activities have included upstream and downstream process development, scale-up, analytical methods development and drug manufacturing for pre-clinical and clinical supplies. Additionally, the Company has partnered with Ayana Pharma to provide liposomal encapsulated drug development services.
According to GlobalData, the demand for Contract Development and Manufacturing Services (CDMO) for biological early-stage drugs is growing in the U.S. This trend is driven by several factors, including improved molecular biological understanding, accelerated market approvals, and the increasing number of novel drug candidates. As the complexity of biologics increases, so does the demand for high-quality development and manufacturing capacities that meet stringent regulatory standards.
However, while there is a growing demand for CDMO services, the capacity to meet this demand is currently a concern. The specific capacity to handle early-stage projects, an area where Scinai BioServices operates, may be strained due to the complex manufacturing routes associated with biologics. Additionally, the BIOSECURE Act, introduced in January 2024, aims to prevent "foreign adversary biotech companies" from receiving U.S. federal funding. According to GlobalData's Pharma Intelligence Center Deal Database, this legislation could impact over 120 U.S. biopharmaceutical drugs in development by companies partnered with Chinese CDMOs and biotechnology companies. Of these, approximately half are in clinical-stage development (Phases I to III) and a third are in early-stage preclinical trials and discovery.
Scinai's new U.S. subsidiary, Scinai Bioservices Inc., aims to serve U.S.-based early-stage biotech companies by providing the required CDMO services that are currently in short supply. This is coupled with growing demand for boutique CDMO services from early-stage biotech companies seeking fast project onset at competitive pricing without compromising on scientific and quality standards. Moreover, Scinai Bioservices Inc. allows early stage biotech startups, supported by U.S. government grant funding, to use their grant money by contracting with us, avoiding any concerns related to the BIOSECURE Act.
Scinai's CDMO business unit is focused on rapid growth, acquiring new clients, and building its reputation and brand awareness. The Company expects revenues from the CDMO business to increase materially in the coming years.
Amir Reichman, CEO of Scinai, commented: "We are thrilled and energized by the opening of our new subsidiary in the U.S. Last week, 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."
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