Simulated Moving Bed (SMB) Chromatography

Complex Emerging Technologies

Separation and Purification of APIs through SMB Chromatography

SAFC Pharma® offers Simulated Moving Bed (SMB) chromatography services starting at early stage materials to commercial-scale capabilities.

SAFC offers
	Small-scale SMB capabilities
	Commercial-Scale SMB capabilities
	Full Regulatory services

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.

Small-Scale SMB

Small-scale SMB processing at Buchs, Switzeralnd, covers 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 available

Commercial-Scale SMB

	First commercial-scale multi-column chromatography unit to be FDA approved for commercial production.
	One of a few units used for commercial manufacturing
	9,000 L (100 kg) liquid starting material capacity
	8,000 L holding reactor tanks
	1,400 L of concentrated material per batch from processing reactors
	cGMP production for clinical or commercial products
	Operates as a Varicol® system
	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

Quality Assurance

SAFC Pharma 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

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

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