Evotec SE and Alpine Immune Sciences said that Evotec’s Seattle-based subsidiary, Just – Evotec Biologics, expanded a multi-year partnership with Alpine for the development of a commercial process for ALPN-303, an engineered TACI domain with improved potency against the B cell cytokines BAFF and APRIL, being developed for the treatment of systemic lupus erythematosus and other B cell-mediated inflammatory and autoimmune diseases. The contract is a continuation of their first-in-human program initiated in 2020 in which Just – Evotec Biologics delivered drug substance materials using their J.DESIGN continuous manufacturing platform for Alpine’s ongoing Phase I study and anticipated Phase II studies of ALPN-303.

Under the expanded contract, Just – Evotec Biologics will use its data-driven technology platform to develop a commercial manufacturing process for ALPN-303. The program includes upstream and downstream process, analytical method and formulation development with a view to support commercial manufacturing of ALPN‑303. Commercial process development activities will be performed at Just – Evotec Biologics’ state-of-the art J.POD biomanufacturing facility located in Redmond, WA.

J.DESIGN, Just – Evotec Biologics’ data-driven, highly automated end-to-end biologics technology platform, employs a series of innovative technologies relying on the use of artificial intelligence, machine learning, intensified and continuous bioprocesses specifically designed for flexible and efficient biologics development, from discovery through to clinical and commercial manufacturing. The advanced Just – Evotec Biologics platform is specifically well suited for monoclonal antibodies and related protein modalities such as Fc fusion proteins. The J.POD facility was designed to support both clinical and commercial manufacturing processes while leveraging its expandable and highly flexible capacity.