CAUSTIC STABILITY (CIP)

Each column of AMBERCHROM™ HPR10 can be cleaned and sanitized-in-place with strong alkaline solution (e.g. 1 N NaOH). This enables to attain higher and more modern CIP/SIP standards compared to traditional reversed phase silica materials.

Stability in 1N NaOH @ 60 °C up to 744 hours

Total Insulin Capacity	1 % insulin Capacity

Amberchrom™ HPR10 resin provides sustained capacity for biomolecules after extended exposure to elevated temperatures (60 °C for 744 hours) with caustic solutions without degradation of its capacity.

MECHANICAL STABILITY

Eearlier generations of polymeric resins suffered from a lack of mechanical stability. The new technology used to manufacture Amberchrom™ HPR10 enables the product to be operated up to pressures of 100 bar.

Unlike older soft gel polymers, Amberchrom™ HPR10 can be used effectively with higher pressure, Dynamic Axial Compression (DAC) column hardware for high thoughput operations.

EXCEPTIONAL SELECTIVITY AND RESOLVING POWER

The unique polymer architecture of Amberchrom™ HPR10 has been engineered to be highly selective to peptides and small proteins. The benefits of selectivity and resolution go directly to the bottom line of the manufacturing process - high yield at high product purity levels.

The below figure demonstrates increased resolution and reduced peak tailing when compared to other polystyrene based polymeric media. Both columns were packed with polystyrene divinylbenzene resins, however the unique pore distribution of Amberchrom™ HPR10 provided a better separation of the peptide mixture.

HIGH CAPACITY

Amberchrom™ HPR10 reversed phase resin was specifically optimized to yield high capacity for peptides and small proteins such as insulin. The benefit of high capacity are superior resolution and the attainment of high loading levels in purification, leading to high throughputs in the manufacturing process. The below table illustrates the high capacity of Amberchrom™ HPR10 resin for biomolecules of various sizes. The "percent of capacity used" is an indication of mass transfer performance and the suitability of the media for a given application.

Capacity vs molecular weight

Dynamic capacity measurements were determined on Amberchrom™ HPR10 using four different molecular weight probes in a 0.1% TFA mobile phase at 152 cm/h. Vancomycin capacity was determined in 0.1M Tris, pH 8.0.

The data show that capacity is highest for molecules under 14,000 MW, and 1% breakthrough capacity drops as a percentage of total dynamic capacity as the MW of the probe molecule increases. As shown above, Amberchrom™ HPR10 resin is best-suited for peptides and small proteins.

COLUMN EFFICIENCIES

Older polymeric materials could not match the high efficiency of silica packings. However, Amberchrom™ HPR10 media provides efficiencies that are identical or better than commercially available silica products.

Efficiencies of several competitive 10 µm silica columns were compared to that of the monosized 10 µm Amberchrom™ HPR10 resin using human insulin.

The figure below demonstrates the results of this comparison, and the high efficiency of Amberchrom™ HPR10 resin.