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 proteinADC
Therapeutic areas
OncologyImmunologyInfectious disease
Upstream
Cell-line developmentFed-batchPerfusionMedia / feed optimizationBioreactor scale-up
Downstream
Chromatography developmentTFF / UF-DFViral clearanceContinuous downstream
Formulation
High-concentration mAbLyophilizationPre-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 / continuousChromatography (downstream)Isolator fill-finish
Established
Aseptic expertise