Capabilities & focus
Process-development services
Formulation developmentProcess characterizationTech transferAnalytical method developmentScale-upLyophilization cycle developmentFill-finish developmentStability studiesDOE studiesQbD developmentPAT integrationProcess validation supportManufacturing readinessContinuous manufacturing designDevice compatibility
Molecule types
Small moleculeMonoclonal antibodyRecombinant proteinmRNA
Therapeutic areas
OncologyInfectious diseaseImmunology
Upstream
Cell-line developmentFed-batchMicrobial fermentation
Downstream
Chromatography developmentTFF / UF-DFViral clearance
Formulation
High-concentration mAbLyophilizationLNP encapsulationPre-filled syringe
PAT tools
RamanNIRIn-line UV
Automation
DeltaVPAS-X MESSCADA / historian
DOE / QbD
DOE (design of experiments)QbD / design spaceRisk assessment (FMEA)Control strategyMultivariate analysisProcess modeling
Technology platforms
Single-use systemsIsolator fill-finishStainless-steel bioreactorsMicrofluidics (LNP)
Advanced isolator-based
Aseptic expertise