Capabilities & focus
Process-development services
Formulation developmentProcess characterizationTech transferAnalytical method developmentScale-upLyophilization cycle developmentFill-finish developmentStability studiesDOE studiesQbD developmentPAT integrationProcess validation supportManufacturing readinessContinuous manufacturing design
Molecule types
Monoclonal antibodyRecombinant proteinADCCell therapymRNA
Therapeutic areas
OncologyRare diseaseImmunology
Upstream
Cell-line developmentMedia / feed optimizationFed-batchPerfusionBioreactor scale-up
Downstream
Chromatography developmentTFF / UF-DFViral clearanceContinuous downstream
Formulation
High-concentration mAbLyophilizationLNP encapsulationPre-filled syringe
PAT tools
RamanNIRCapacitance / biomassOff-gas analysis
Automation
DeltaVPAS-X MESAmbr (automated micro-bioreactor)
DOE / QbD
DOE (design of experiments)QbD / design spaceRisk assessment (FMEA)Control strategyMultivariate analysisProcess modeling
Technology platforms
Single-use systemsPerfusion / continuousIsolator fill-finishMicrofluidics (LNP)Chromatography (downstream)
Advanced isolator-based
Aseptic expertise