- 8 commercial APIs
- 16 intermediates
- 20 completed tech transfers
- Approved to supply in more than 60 countries
Commercial Experience
Chemistries/Reactions
- Organometallic (Grignard)
- Gaseous HCl
- Acetylene Chemistry
- Friedel-Crafts Chemistry
- Cyanation
- Carbonylation
- Heterogeneous/homogenous catalytic reactions
- Hydride
- DIBAL reductions
- Chlorinated Solvents
- Hydrogenation (low + high pressure)
- O2 sensitive
- Coupling, protection/deprotection reactions
Manufacturing Capabilities
- High potent API (HPAPI) up to OEB4
- Hastelloy and glass lined reactors ranging from 1,000 L to 12,000 L
- Low and high pressure hydrogenation
- Carbonylation up to 6 bar
- Crystallization
- Inverting bag centrifuges
- Peeler centrifuges
- Filter, agitated, tumble and fluid bed drying
- COMIL and Pin milling
- Chromatography
Process Evaluation and Optimization
Dedicated technical operations teams and lab scale process equipment supports development work including:
- Transfer of new process
- Process optimization
- Troubleshooting/investigations
- Waste stream characterization
- PPQ efforts
- Raw material supplier evaluation
Analytical Testing
Full support for method validation, method transfer, incoming raw material testing, in-process and final release testing. Analytical methods include:
- HPLC (reverse/normal phase and ion exchange, with UV/Vis, RI, fluorescence, ECD and ELS detection)
- UPLC
- GC (direct injection and headspace analysis with FID and TCD detection)
- ICP-OES, ICP-MS, GC-MS and LC-MS
- Spectroscopy (FT-IR, UV/Vis and AA)
- Powder X-Ray Diffraction, DSC Optical Electron Microscopy Surface Area and Particle Size Analysis
- Moisture analysis (KF and water activity)
- Cleaning Methods (LC and TOC)
- Microbiology Testing
- ICH Stability Storage and Testing