Capabilities & focus
Process-development services
Formulation developmentProcess characterizationTech transferAnalytical method developmentScale-upLyophilization cycle developmentFill-finish developmentStability studiesDOE studiesQbD developmentPAT integrationProcess validation supportManufacturing readiness
Molecule types
Monoclonal antibodyRecombinant proteinViral vector (AAV/LV)Plasmid DNA
Therapeutic areas
OncologyRare diseaseInfectious disease
Upstream
Cell-line developmentFed-batchTransient transfectionMicrobial fermentation
Downstream
Chromatography developmentTFF / UF-DFViral clearance
Formulation
High-concentration mAbCryopreservation
PAT tools
RamanNIRCapacitance / biomass
Automation
DeltaVAmbr (automated micro-bioreactor)
DOE / QbD
DOE (design of experiments)QbD / design spaceRisk assessment (FMEA)Control strategyMultivariate analysisProcess modeling
Technology platforms
Single-use systemsStainless-steel bioreactorsChromatography (downstream)
Established
Aseptic expertise