P26

Sponsor’s options for bioproduction site: advantages, risks and challenges

L Dejoint(1) C Rochon(1) B Caumes(1) C Maheux(1) A Hadri(1)

1:INITS

The production of biological molecules (cell and gene therapy products, Extracellular vesicles, mAb…) is a complex and highly regulated process. Sponsors establish a roadmap crossing non-clinical, CMC and clinical aspects and must decide fairly quickly whether they wish to invest in internal production capacities or subcontract to CDMOs, for the R&D and/or GMP part. . These approaches offer advantages but also risks and challenges. An alternative model is offered by Inits SMO (shared manufacturing organization) where the sponsor carries out its own production of DS GMP in the qualified and equipped premises of Inits SMO. Depending on the needs and expectations of the sponsor, all options can be evaluated and will condition the life cycle of the product.