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. Heparin HyperD M can be cleaned with sodium hydroxide in concentrations of 0.01 to 0.1 M.
The non compressible HyperD matrix can withstand very high flow rates without any risk of bed collapse. As a result, Heparin HyperD M 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.
Heparin HyperD M maintains high binding capacity, even at 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 for ATIII is higher than 25 UI/mL even at 600 cm/h with a 10 cm bed height.
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