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SMB Chromatography

Accelerate Your API Purification Scale-Up

Simulated Moving Bed (SMB) chromatography 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 and has proven to be cost effective and environmentally friendly, using up to 90% less solvent than similar chromatographic purification schemes.

Commercial-scale SMB technology is available through our facility in Arklow, Ireland.

purification-scale-up

Applications

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:

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

Quality Assurance

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

Commercial-Scale SMB

The SMB unit located in Arklow 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.

The SMB is supported by an extensive, dedicated stainless steel tank farm. 18 tanks, ranging in size from 650 to 10,000 litres marshal the eluent, feed, extract and Raffinate streams. Solvent is continuosly recovered and recycled via a pair of falling film evaporators, control of which is via the SMB computerised operating system.

  • 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%
  • Six-linked 45 cm diameter purification columns

Sample of Commercial Projects at Arklow

  • LEXAPRO® (SSRI) for Forest Laboratories
  • Narcolepsy drug for Cephalon

SMB Chromatography Process Scheme

smb-chromotography