Innovative solutions for
Biosimilars
- Monoclonal antibodies(mAbs)
- Therapeutic proteins
- Insulin
Vaccines
- Human vaccines
- Veterinary vaccines
- mRNA vaccines
Advanced
therapies
- Cell therapy
- Gene therapy
Blood plasma
- Plasma derived therapies
- Plasma fractionation
Formulation
& fill-finish
- Ophthalmic
- Metered dose inhaler (MDI)
- Large volume parenteral
- Small volume parenteral
- Microspheres & depot
Concept design
- Project description review
- Production programme review
- Process technology review
- Gmp requirements review
- Equipment program review
- Layouts review
Basic design
- Process flow diagrams
- P&ID development & review
- Utility requirements and equipment capacity
- Process automation concept
Detailed design
- Equipment & Functional specification
- Equipment layout
- Vessel & platform design
- Piping engineering
- Equipment movement plan
- Major-component list
- 2D & 3D drawings with E-plan
Manufacturing
& compliance
- CFT risk assessment using FMEA for design, manufacturing and automation
- Robust material inspectionsystem
- Plasma cutting
- Cold fusion of pipe welding
- Process piping
- Mechanical & processautomationintegration
- Internal FAT
FAT
- Factory acceptance test
- Site acceptance test
- Implementation support
- PQ assistance (if applicable)
- Operator trainings
Service
& support
- On-site service
- Spare part management
- Upgradations
- Remote access
- Preventive maintenance
- CEP
Concept design
- Project description review
- Production programme review
- Process technology review
- Gmp requirements review
- Equipment program review
- Layouts review
Basic design
- Process flow diagrams
- P&ID development & review
- Utility requirements and equipment capacity
- Process automation concept
Detailed design
- Equipment & Functional specification
- Equipment layout
- Vessel & platform design
- Piping engineering
- Equipment movement plan
- Major-component list
- 2D & 3D drawings with E-plan
Manufacturing & compliance
- CFT risk assessment using FMEA for design, manufacturing and automation
- Robust material inspectionsystem
- Plasma cutting
- Cold fusion of pipe welding
- Process piping
- Mechanical & processautomationintegration
- Internal FAT
FAT
- Factory acceptance test
- Site acceptance test
- Implementation support
- PQ assistance (if applicable)
- Operator trainings
Service & support
- On-site service
- Spare part management
- Upgradations
- Remote access
- Preventive maintenance
- CEP