Core Viewpoint - Scinai Immunotherapeutics Ltd. has established a U.S.-based subsidiary, Scinai Bioservices Inc., to enhance its Contract Development and Manufacturing Services (CDMO) offerings, addressing the growing demand for these services in the U.S. biotech sector [1][6]. Company Overview - Scinai Immunotherapeutics is a biopharmaceutical company focused on developing inflammation and immunology biological products and providing CDMO services through its Scinai Bioservices business unit [1][8]. - The company launched its CDMO business unit in 2024, operating from a facility in Jerusalem, Israel, which includes 1,850 square meters of clean rooms and laboratories compliant with cGMP conditions [2][8]. CDMO Business Development - The CDMO unit has executed drug development projects for nine biotech companies, covering various aspects such as process development, scale-up, and drug manufacturing for pre-clinical and clinical supplies [3][8]. - Scinai has partnered with Ayana Pharma to provide specialized liposomal encapsulated drug development services [3]. Market Demand and Trends - There is a growing demand for CDMO services for biological early-stage drugs in the U.S., driven by improved molecular biological understanding, accelerated market approvals, and an increasing number of novel drug candidates [4]. - The complexity of biologics manufacturing is leading to a heightened demand for high-quality development and manufacturing capacities that meet stringent regulatory standards [4]. Challenges in the Industry - Despite the growing demand for CDMO services, there are concerns regarding the capacity to meet this demand, particularly for early-stage projects due to complex manufacturing routes associated with biologics [5]. - The BIOSECURE Act, introduced in January 2024, may impact U.S. biopharmaceutical drugs in development by companies partnered with Chinese CDMOs, potentially affecting over 120 drugs, with many in clinical-stage development [5]. Strategic Initiatives - The new U.S. subsidiary aims to serve early-stage biotech companies by providing much-needed CDMO services, allowing these companies to utilize U.S. government grant funding without concerns related to the BIOSECURE Act [6]. - Scinai's CDMO business unit is focused on rapid growth, acquiring new clients, and enhancing brand awareness, with expectations of significant revenue increases in the coming years [7][8]. Leadership Commentary - The CEO of Scinai expressed enthusiasm about the new U.S. subsidiary, highlighting the signing of the first contract with Serpin Pharma for clinical manufacturing, which is expected to enhance the prospects of the CDMO unit [8].
Scinai Immunotherapeutics Establishes U.S. Subsidiary for CDMO Business Unit, Scinai Bioservices Inc.