Engineering & Manufacturing
Engineering & Manufacturing
Whatever your needs, from preclinical development through to development of manufacturing of the active pharmaceutical ingredient (API process development) for clinical trials to development of your API manufacturing process, Olon Ricerca Bioscience offers you flexible access to a broad spectrum of manufacturing process development, pharmaceutical process development and manufacturing expertise.
This expertise includes specialist scientists with experience in development manufacturing, process development chemistry, pharma process development, manufacturing route and manufacturing and development determination.
Our experts specialize in establishing process of manufacture, manufacturing development, establishing your active pharmaceutical ingredient manufacturing process, and chemical manufacturing process.
Our three-decades of experience also includes process chemistry and development, analytical chemistry, and engineering capabilities. We are proficient in a diverse range of organic chemical reactions and excel at combining them into a safe, reliable, efficient, and cost-effective manufacturing process for your APIs, intermediates, regulatory starting materials and performance chemicals. All capabilities are ideal for establish also your commercial manufacturing process.
Olon Ricerca Bioscience offers flexible access to a broad spectrum of manufacturing process development, pharmaceutical development and manufacturing expertise
Process chemistry
- Process scale up and demonstration
- Process validation
- Engineering data acquisition
- Technology transfer to commercial scale
- Preparation of active pharmaceutical ingredients (APIs) under cGMP controls
- Preparation of intermediates, regulatory starting materials and performance materials
- Multi-kilogram to multi-ton amounts (process-dependent)
- Manufacturing in support of pre-clinical/clinical, market development and commercial requirements
Tools & Capabilities
Reaction Systems
- 17 reactor systems
- Ancillary equipment
- Total capacity: 17,000 liters
- Volumes: 40 to 3,000 liters
- MOC: GLS and 316SS
- Pressure: FV to 400 psig
- Temperatures: - 55 to +165°C
Solid/Liquid Separation Systems
- Pressure/vacuum filters
- Centrifuges
Liquid Separations
- Batch distillation– custom design
- Thin-film/wiped film evaporator
Flash Chromatography
- 50-liter cartridge
- SG and AC
Drying
- Dynamic – Rotary Cone
- Static – Vacuum Shelf
Support Equipment
- Solid/Liquid Charging Systems
- Dedicated Vacuum Systems
- Isolation Systems/Facilities
- Electronic Data Capture
cGMP Kilo Labs
- Independent reaction/product isolation areas
- Finishing suites suitable for drying, milling and packaging with separate vestibule access
- Clean corridor / air lock access that assures product isolation / integrity
- Dedicated HVAC System that provides filtered air, maintains pressure barriers and provides continuous monitoring/alarming
- Process equipment for reaction, purification, isolation, drying and milling
- Dryers: 4.3 - 7.6 ft 3
- Rotary Evaporation: Up to 22 liters
- Reaction Equipment: Round bottom flasks up to 50 liters
- Milling: Quadro Co-Mills
