Heparin HyperD® M Affinity Chromatography Sorbent by Pall Life Sciences Products - Biopharmaceutical Division

BioSepra® Heparin HyperD® M composite chromatography sorbent is the most technologically advanced high speed, high capacity affinity preparative sorbents for the purification of biological molecules that bind to heparin, such as coagulation factors, growth factors, lipoproteins... The sorbent provides high binding capacity at high flow rates.
Heparin HyperD M unique composite structure was chosen to provide superior dynamic capacity at high linear velocities.

HyperD sorbent is comprised of a porous rigid mineral bead containing heparin bound hydrogel filled pores. BioSepra holds U.S. patent 5,268,097 (1993) covering the unique properties of HyperD sorbents and U.S. patent 5,234,991 (1987) on other “supported gel” or “gel-in-a-shell” sorbents.
Heparin HyperD M has an average particle size of 80 µm and is used for preparative scale purification of ATIII. The sorbent can be packed in column sizes from ml to more than hundred liters and operated at high flow rates with low backpressure.
The main benefits of Heparin HyperD M sorbent are:

• Rapid packing due to the high density of heparin sorbent which settles in a few minutes.
• HyperD sorbent is very rigid and allows the use of high flow rates without pressure increase or shrinking or swelling of the sorbent.
• Heparin leakage is minimized due to the stable chemical link of the heparin molecule to the sorbent.

Heparin HyperD M is available as ready-to-use labpacks suspended in 1 M sodium chloride with 20 % ethanol as bacteriostatic. Larger bulk quantities are also available upon request.

Capacity
Heparin HyperD M maintains high binding capacity, even at extremely high linear velocity. It is commonly used at large scale for the production of pharmaceutical grade ATIII. Production scale columns (>100 L) can be operated at high linear velocities (> 200 cm/h) while maintaining capacity with minimal backpressure. Its capacity is higher than 25 UI/mL even at 600 cm/h with a 10 cm bed height.

Stability
The non compressible HyperD matrix can withstand very high flow rates without any risk of bed collapse. As a result, Heparin HyperD M can be used with LPLC, MPLC or HPLC systems. An HPLC purification can be performed in less than 10 minutes using a 0.46 I.D. x 5 cm column. Faster purification saves user time and preserves the biological integrity of the purified proteins. The mechanical properties of Heparin HyperD M sorbent remain constant across a wide range of velocities. Minimum pressure drop, even at high linear velocity, assures direct, predictable scale up to any volume.

Mechanical and Chemical Stability
The pH stability is the same as for the free soluble heparin: between 3 and 13. Dissociating agents and detergents have generally no effect on heparin sorbent. Treatments of Heparin HyperD M sorbent with 8 M urea, 6 M guanidine hydrochloride and 1% Triton X-100 led to no change when tested with bovine ATIII or Hu ATIII. Heparin HyperD M can be cleaned with sodium hydroxide in concentrations of 0.01 to 0.1 M.

Validation
The heparin used for the production of Heparin HyperD M has a North American origin and is from porcine intestinal mucosa. The heparin is produced in compliance with the applicable requirements of the FDA’s Good Laboratory Practices and Good Manufacturing Practices regulations.
A validation file can be provided to industrial customers to support the regulatory requirements for producing clinical and approved therapeutics.