Just – Evotec Biologics and Alpine Immune Sciences expand their partnership

Evotec SE and Alpine Immune Sciences said 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 enhanced potency against B-cell cytokines BAFF and APRIL, being developed for the treatment of systemic lupus erythematosus and other B cells – mediated inflammatory and autoimmune diseases. The contract is a continuation of their first in man program launched in 2020 in which Just – Evotec Biologics delivered drug substance materials using their J.DESIGN continuous manufacturing platform for the Alpine’s ongoing phase I study and planned 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 to support the commercial manufacture of ALPN-303. Commercial process development activities will be performed at Just – Evotec Biologics’ state-of-the-art J.POD biofabrication facility, located in Redmond, WA.

J.DESIGN, Just – Evotec Biologics’ highly automated and data-driven end-to-end biologics technology platform, utilizes a series of innovative technologies based on the use of artificial intelligence, machine learning, intensified and continuous bioprocessing purpose-built for flexible applications and efficient biologics development from discovery to clinical and commercial manufacturing. The advanced Just – Evotec Biologics platform is particularly well suited for monoclonal antibodies and associated protein modalities such as Fc fusion proteins. The J.POD facility was designed to support clinical and commercial manufacturing processes while leveraging its scalable and highly flexible capability.