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 various 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 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:
    • 316L 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
an image of ampac testing facility
6 x 800 mm
an image of ampac testing facility
5 x 1000 mm

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
    • >99.98% solvent recycled
    • >98.5% ep