Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) announced that its project to advance a robotic aseptic fill and finish platform has been approved for expanded support by the Israel Innovation Authority. The approval allows the company to utilize the full approved grant budget of NIS 5 million over two years, with approximately 66% of the funding being non-dilutive. This financial support is significant for maintaining disciplined capital allocation while enhancing manufacturing capabilities.
The program specifically supports the acquisition and validation of a fully automated robotic-arm aseptic fill and finish system that must align with stringent EU GMP Annex 1 standards. Validation of this advanced system is targeted for completion by the third quarter of 2026. This timeline establishes a clear benchmark for the integration of this technology into Scinai's operations.
This investment is a key component of Scinai's broader contract development and manufacturing organization expansion strategy. The strategy was bolstered by the company's acquisition of Recipharm Israel Ltd. and the establishment of a commercial collaboration with Recipharm. These moves have strengthened Scinai's integrated two-site manufacturing platform in Israel, which includes a biologics development and clinical manufacturing facility in Jerusalem and a small-molecule API development and GMP manufacturing site in Yavne.
The enhancement of sterile biologics capabilities through this robotic platform is crucial for the biopharmaceutical industry. Sterile fill and finish is a critical step in the manufacturing of biologic drugs, including monoclonal antibodies and other complex therapies. Automation and robotics in this process can improve precision, reduce contamination risks, and increase efficiency, which are vital for producing safe and effective medicines. The company's CDMO unit provides fee-for-service solutions to biotech and pharmaceutical companies, supporting clients from preclinical development through Phase I/II clinical supply.
Through its strategic commercial collaboration with Recipharm, detailed in company materials, Scinai offers clients a defined pathway from early clinical development to late-stage and commercial manufacturing within Recipharm's global network. This structure is designed to enable continuity of development, streamlined tech transfer, and reduced scale-up risk as drug programs advance. The latest news and updates relating to SCNI are available in the company's newsroom at https://ibn.fm/SCNI.
The importance of this development extends beyond Scinai's immediate business. The expansion of advanced, automated aseptic manufacturing capacity supports the broader biotech ecosystem, particularly for early-stage and emerging companies that rely on CDMOs to bring their innovations to clinical trials. By investing in technology that meets high regulatory standards, Scinai is contributing to the infrastructure needed to develop next-generation biologics safely and efficiently. This has implications for drug development timelines, cost management for biotech firms, and ultimately, patient access to new therapies.
In parallel to its CDMO operations, Scinai is advancing a focused immunology research and development pipeline. This includes PC111, a first-in-class anti-FasL monoclonal antibody targeting orphan dermatologic indications, and next-generation NanoAb-based programs in inflammation. The company seeks strategic partnerships to advance these programs. The grant-supported manufacturing advancement strengthens the foundation supporting both its service business and its internal R&D ambitions.
