capability
Biomanufacturing (CDMO/CMO)
Contract development & manufacturing of biologics, ATMP, mRNA.
Where it's used
Bioproduction CDMO/CMO (biologics/ATMP/mRNA)
Contract development and manufacturing organizations providing specialized infrastructure for advanced biopharmaceuticals.
Process validation and qualification (CRO)
CRO-delivered three-stage process validation and IQ/OQ/PQ qualification of biopharma equipment — media fills, cleaning validation, CSV and viral clearance under FDA/EudraLex Annex 1 cGMP.
Scale-up centers for innovative biologic small-batch production
Public-private manufacturing-innovation institutes that operate shared pilot- and demonstration-scale biomanufacturing facilities, letting a biologic developer run small-batch production and prove out a process before committing capital to a dedicated commercial-scale plant.