Scinai Immunotherapeutics has expanded its biopharmaceutical CDMO capabilities with a new US-based subsidiary, Scinai Bioservices.
The offshoot, which will be based in Delaware, will be responsible for pre-clinical and clinical cGMP manufacturing, upstream and downstream process development, scale-up and the development of analytical methods.
This US expansion follows Scinai's movement into the CDMO business, which began in 2024 with the company's main facility in Jerusalem, Israel.
CDMOs gain in popularity
According to GlobalData CDMOs offering services in the early-stage biologics niche have been more sought after in recent years.
This is likely driven by the enhanced understanding of molecular biology, as well as the accelerated regulatory approvals that biologics are currently experiencing.
There has also been a huge uptick in new drug candidates in this space, which are also increasing in complexity.
This means that biotech and pharmaceutical companies may need to access quality development and manufacturing services to successfully commercialise their therapeutic.
With a rapid increase in demand for biopharma CDMO services, the capacity to meet this demand must keep up with this growth.
The BIOSECURE Act also threatens to impact more than 120 biopharmaceuticals currently in development, as they have utilised Chinese CDMOs or biotech partners in the production process.
Scinai's US subsidiary
To overcome the challenges of the BIOSECURE Act and ensure that US biopharma players have access to a reliable CDMO, Scinai aims to provide the required CDMO services currently in short supply.
The company will also offer boutique CDMO services to early-stage biotechs at a competitive price, while still allowing access to the US Government grant funding.
Scinai is currently focused on acquiring new clients, while also building its reputation as a trusted CDMO partner.
CEO of Scinai, Amir Reichman, commented: "We are thrilled and energised by the opening of our new subsidiary in the US.
"Last week, we signed our first contract with US customer, Serpin Pharma, to support their clinical manufacturing. I believe that our expanded presence in the US will significantly enhance the prospects of our CDMO unit."