Manufacturing Services USA

Services

Together with our longstanding network of carefully selected AMERICAN associates and unique subcontractors (CRO/CDMO) that are fully committed to comply with our various agreements and policies we are offering a reliable, comprehensive and transparent service for:

Custom / Contract Manufacturing / Tolling (cGMP and non-GMP)
Custom synthesis on FTE & FFS service model (CRO)
Literature and Patent Research
Process Research
Process Development
Bench-Scale Lab, Kilo Lab and Pilot Plant Development
Process Optimization
Commercial manufacturing

Large-scale high quality pharmaceutical intermediates and fine chemicals (non GMP)

Capabilities include:

Boc protected intermediates
Distillation (ultra high vacuum and thin film)
High temperature chemistry
Corrosive chemistries (thionyl chloride, phosphorus oxychloride)
Cryogenic reactions
Continuous processing – hazardous materials, organometallic chemistry
Handling triphosgene – chloroformates, carbamates

Capacity and instrumentation

Over 23,000 gallons (87,000 L) of reactor capacity from 5 gallons (20 L) to 2000 gallons (7500 L)

Two processing lines of 2000 gallon glass-lined reactors and one processing line of 1000 gallon glass-lined reactors in main manufacturing area

Stainless Steel  and glass lined reactors up to 2000 gallons
2,000 gallon Hastelloy C reactor
Pilot facility with 5 to 100 gallon equipment
Hydrogenation unit rated at 300 psi
A state of the art high vacuum system capable of vacuums down to < 1 torr
A 25 plate distillation unit with engineered packing  and fraction divider capable of processing 12,000 kg per day.
Three thin film evaporators
Four centrifuges, two rated for acidic products
Hastelloy and tantalum overheads
High temperature reactions up to 300^oC
Low temperature reactions down to -80^oC

GMP and non-GMP Custom Synthesis involving

Fluorination
Hydrogenation
Cyanation 
Azidation 
Cryogenic Chemistry 
Methylating Agents 
Chromatography 
Heterogeneous/Homogeneous Catalysis 
Nitrations 
Metal-Mediated Couplings 
Alkylations 
Acylations 
Nucleophilic Aromatic Substitution Reactions 
Pyrophoric Reagents 
Synthesis of Reference Standard Samples 
Organic Chemical Process Development 
Advanced technology: Biocatalysis

Kilo-Scale GMP Facility

Annual Capacity 500 kg

Equipment

2 cGMP suites & 1 non-cGMP suite

2 in each of 2 cGMP Kilo rooms
2 in the Continuous Lab (non-cGMP)

6 Support Tanks for each cGMP Hood (24 total)

Hastelloy and 316 L SS
10 gal and 20 gal
Agitated and Jacketed

Capabilities

Capable of producing quantities of API in the range of up to ~2 kg/day, depending upon the nature and complexity of the API process.

Metric Ton-Scale cGMP Facility

Annual Capacity 60 MT

Equipment

Eight reactors in a single reactor suite
Dryer/centrifuge charge & discharge rooms
Filter/dryer charge and discharge rooms
2 Process Equipment Trains, 4 Reactors per Train

1,000 gal reactor, 2,000 gal reactors
Hastelloy
Glass-lined Steel

2,000 gal Hastelloy Filter Reactor (custom design)

Transfer Booths
Liquid booths – Level 1
Solids booths – Level 2

Filtration & Drying
Filter Dryer
Inverting Basket Centrifuge
Conical Dryer