Certain features of will be down for maintenance Saturday afternoon/evening, February 24th starting at 3:00 pm CT until 9:00 pm CT.

Please note that you still have telephone and email access to our local offices. We apologize for any inconvenience.

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
Contact SAFC

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