Praesto® Jetted A50 HipH

点击数：316

通过与Repligen合作（采用NGL – Impact® A Hi pH配基），Praesto Jetted A50 HipH是Purolite在亲和层析填料上最新的技术创新。Purolite全新的蛋白A填料解决了那些对pH敏感的蛋白因传统蛋白填料需要低pH洗脱的困扰。Jetted A50 HipH可以用于那些敏感的蛋白。

相较于传统的单克隆抗体纯化工艺去除杂质，利用Praesto喷射A50 HipH独特的洗脱特性可以得到显著的提升。

 Praesto Jetted A50 HipH的裸球是使用专利的喷射技术生产的，一种创新的工艺可以生产粒径分布非常窄的均一粒径的琼脂糖裸球。这些均一粒径的裸球对比常规的填料有着优异的性能表现。
 

有关我们的Protein A填料的常见问题，请访问我们的FAQs页面。

Product PDF
Resin Selection
Resins data
User Instruction

PRINCIPAL APPLICATIONS

  • MAb Purification

REGULATORY APPROVALS

  • Manufactured under cGMP conditions

ADVANTAGES

  • Manufactured using patented Jetting technique
    Uniform particle size
  • Religen ligand NGL-Impact® A Hi pH
  • Dynamic binding capacity up to ~60 mg/hIgG/ml resin
    Alkaline stable in 0.1 M NaOH for over 100 cycles
  • Enhanced pressure/flow performance – Flows are up to 250 cm/h in a 60 x 20 cm column
  • Manufactured with reduced environmental impact

TYPICAL PACKAGING

  • Bulk Resin
  • Production-Scale OPUS® Columns
  • OPUS® Robocolumns®
  • OPUS® MiniChrom Columns
  • HT Columns
TYPICAL PHYSICAL & CHEMICAL CHARACTERISTICS: 
Polymer StructureHighly cross linked agarose 
AppearanceSpherical, uniform size beads supplied in 20% ethanol slurry. On request 2% benzylalcohol
Functional GroupProtein A 
Average Particle Size (d50ᵥ), μm50 µm 
Dynamic Binding Capacity (min.)- 3 minutes residence timeUp to ~60 mg hIgG/ml resin 
Pressure/flow (min.) – at 3 bar in a 2.6 x 20 cm column (pressure-packed at 4 bar)Up to 250 cm/h (20 x 60 cm column) 
pH stability, CIP (short term)2 – 14 
pH stability, working range3 – 12 
Recommended Storage2 – 8 °C 
Recommended Storage20% ethanol 

Praesto® Jetting technology creates enhanced Protein A agarose resins for bioprocessing of recombinant proteins and monoclonal antibodies (mAbs)

Peformance data

DBC1
DBC2

Figure 2a and 2b Breakthrough capacity for polyclonal immunoglobulin G (hIgG) and an IgG1 monoclonal antibody (mAb 1) of Praesto Jetted A50 HipH, Praesto Jetted A50 and MabSelect SuRe LX.

Praesto Jetted HipH A exhibits excellent capacity for polyclonal human immunoglobulin G and an IgG1 subclass monoclonal antibody. Excellent capacity and selectivity are available for molecules previously sensitive to low pH elution. An equivalent capacity to the market leading protein A resin is achievable using Praesto Jetted HipH A.

Figure 3 Sodium hydroxide stability of Praesto Jetted A50 HipH. Tested with hIgG at selected exposure intervals.

Sodium hydroxide (NaOH) is commonly used in
bioprocessing as an industry standard for cleaning in place, as such it is increasingly important for capture resins to be extremely alkaline stable. Sodium hydroxide exhibits high efficiency in removing bound proteins, nucleic acids, and lipids from bioprocess resins, alleviating the risk of fouling on heavily burdened protein A columns. Praesto Jetted HipH A50 has been shown to be alkaline stable for over 100 hours exposure to 0.1 M NaOH.

Process performance

Purification performance of Praesto Jetted A50 HipH using elution conditions from acidic to mild was investigated. Quantitative elution was achieved up to pH 5.0 using a clarified harvest of an IgG1 subclass monoclonal antibody with recovery levels greater than 95% and elution within 2.5 column volumes. Leached Protein A levels determined to be similar to that of Praesto Jetted A50.

Process performance – Customer evaluation

Customer evaluations have shown the effect of using the unique properties of Praesto Jetted A50 HipH to elute at much higher pH when compared to conventional protein A chromatography. Two mAbs were tested, listed as mAb 2 and mAb 3.
Minimal impact on purity is observed by increasing the elution pH of the buffer to elute mAb 2 and mAb 3. The log reduction in host cell proteins and separation of the target molecule from residual DNA is markedly improved by eluting at a higher pH.