Simulated Moving Bed (SMB) Chromatography

SAFC offers separation and purification of APIs through SMB chromatography services starting at early stage materials to commercial-scale capabilities. SMB chromatography is a cost effective and environmentally friendly technology, using up to 90% less solvent than similar chromatographic purification schemes. It combines the advantages of high yields, high purity and accelerated scale-up for clinical to commercial-scale API purification. This chiral chromatography based technology works at the molecular level to separate active and non-active enantiomers for active ingredient production.

Used when affinity differences between molecules are very small, SMB chromatography is best suited to handle removal steps of a single impurity and can be considered the technology of choice for following applications:

  • Enantiomer purification
  • Chiral and other binary-like separations
  • Diastereoisomers

Small-scale SMB Capabilities

Early-stage material processing for programs requiring purification to 100 g of active product per day.

  • CSEP 916 SMB unit from Knauer
  • Column dimensions to 40 mm I.D.
  • cGMP processing available
  • Seamless technology transfer to commercial-scale

Commercial-Scale SMB Capabilities

SAFC’s Commercial-Scale SMB unit is the first commercial-scale multi-column chromatography unit to be FDA approved for commercial production. One of a few units used for commercial manufacturing:

  • cGMP production for clinical or commercial products
  • Fully automated, back-integrated and temperature controlled
  • Operations on a 24/7 schedule
  • Production train including SMB unit, four glass-lined reactors (3,000 – 8,000 L), Hastelloy® dryer and 2,000 L distillation unit
  • Output production to 40 kg of product/day with operational reliability of 95-98%

Quality Assurance Program

SAFC has a comprehensive quality assurance program in place for all its processes, including SMB, with:

  • Over 53 active DMFs in place
  • Purification to industry cGMP and ICH Q7A standards
  • Commercial-scale system including built in HPLC quality control unit for automated sampling and HPLC quality profiles generation
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