AFC has decades of experience conducting chromatographic separations at commercial scale in a highly regulated environment. Our Simulated Moving Bed (SMB) processes can be developed in a few weeks and are easily scalable. In many cases, scale-up from gram to multi-ton quantities can be achieved in less than six months.
Our services include SMB screening, method development, proof-of-concept demonstration, and production of gram to multi-ton quantities of intermediates and APIs. AFC operates the largest cGMP SMB unit in the US (5 x 1,000 mm), which supports commercial scale API production of hundreds of metric tons per year. Our facilities include kilo-scale and pilot scale units to support smaller quantities also under cGMP conditions.
The SMB process has been inspected and approved by the FDA for manufacturing of APIs. AFC has 4 registered products with regulatory authorities (FDA/EMA) using SMB technology.
Typical Applications are:
- Chiral separations
- Separation of diastereomers & regioisomers
- Removal of troublesome or genotoxic impurities
- Other complex separations
AFC has Multiple SMB Units Capable of Manufacturing at All Scales of Production
Laboratory Scale: 8 x 4.6 mm & 8 x 10 mm
- R&D (non GMP)
- Columns: 10 mm x 10 cm
- Pumps: Dual piston pumps
- Temperature controlled
- Application: Method Development and Optimization Proof of Concept
Kilo Scale: 8 x 50 mm
- cGMP facility
- Columns: 50 mm x 10 cm
- Pumps: Dual piston pumps
- Temperature controlled
- Product recovery: Two 20 L (0.02 m³) evaporators (continuous)
- Application: Production of non-cGMP and cGMP clinical trial material. Production rate 0.5 – 3 kg of enantiomer per day
Pilot Scale: 6 x 75 mm, 8 x 100 mm, & 8 x 200 mm
- cGMP facility
- Columns:
- 316 L (0.316 m³) Stainless steel columns
- 100 mm or 200 mm x 10 cm
- Temperature controlled
- Product recovery: Two falling film evaporators
- Application: Production supports phase I through commercial material. Production rate 8 – 50 kg of enantiomer per day
Commercial Scale: 6 x 800 mm & 5 x 1,000 mm
- 6 x 800 mm
- 165 kg CSP
- 50 to 200 MTA Feed
- >95% on stream factor
- >99.98% solvent recycled
- >98.5% ep
- 5 x 1000 mm
- 215 kg CSP
- 75 to 300 MTA Feed
- >95% on stream factor
- >99.9% solvent recycled
- >98.5% ep