- INITS and FyoniBio announce a strategic collaboration to provide biotech clients with an integrated path from early R&D to GMP-compliant clinical production.
- The partnership combines FyoniBio’s cell line and process development capabilities with INITS’ GMP production, enabling drug substance batches up to 400 L and end-to-end clinical manufacturing support.
INITS, a French biopharmaceutical service company, and FyoniBio, a German cell line and process development specialist, have entered a strategic collaboration aimed at offering biotech companies fully integrated biologics production. The partnership is designed to cover all stages from R&D through GMP-compliant clinical supply.
The collaboration centres on INITS’ Shared Manufacturing Organization (SMO), a concept planned to be operational in Q2 2026. The SMO allows clients to implement their own processes for preclinical and clinical batches while retaining full control, with guidance from INITS to ensure GMP compliance.
FyoniBio will provide robust cell line and process development services, including master cell bank generation, using its CHOnamite®, CHOFlow®, and GlycoExpress® platforms. These capabilities extend to monoclonal antibodies, biosimilars, hormones, blood factors, fusion proteins, and other complex recombinant proteins. The companies will produce drug substance clinical batches of up to 400 L at INITS’ Montpellier site, with INITS overseeing project management, quality assurance, regulatory support, and supply. INITS will then handle drug product manufacturing, packaging, release, and delivery to clinical centres.
“Our partnership with INITS brings together two complementary strengths. FyoniBio’s broad capabilities in cell line and process development align seamlessly with INITS’ new GMP facility.”
Lars Stöckl, Managing Director of FyoniBio
Amel Hadri, CEO of INITS, added: “This collaboration with FyoniBio is a major step forward for INITS. By combining our regulatory and GMP expertise with their world-class cell line and process development capabilities, we can offer biotech innovators a truly integrated path from lab to clinic.”
