Product Code | 6701 |
Bead Size | 60-160um |
Agarose concentration | 4% |
Spacer arm | 5 atoms |
Flow rate | 500cm/h* |
Cleaning | 20mM sodium acetate, pH 4.5 |
Storage conditions | 0.1M sodium acetate, 50% glycerol, pH 4.5, 2-8C |
Reactive group concentration | >30mg/ml |
Functional Ligand | Pepsin |
Leaching | <0.1ppm |
pH stability range | 2-4 |
Chemical stability | Common buffers at pH optimum |
Drug master file | U.S. Food & Drug Administration |
*Flow rate determined in a 1.5x5cm column
-For F(ab) production via enzymatic cleavage with pepsin
-High-grade immobilized pepsin is very stable
-Very low levels of leaching
-cGMP manufacturing; Regulatory Support File available
-DMF with USFDA
Pepsin Actigel is made by immobilizing high-grade, porcine-derived pepsin onto Sterogene's Actigel ALD. This ensures an exclusively uniform, stable secondary amine linkage between the reactive monoaldehyde groups of the activated resin and the primary amino groups of the pepsin.
Coupling efficiency is simply a function of loading, so higher pepsin concentrations are available upon request, if desired.
lgG cless anitbodies are known to exhibit different sensitivites to pepsin cleavage: for example, lgG; and lgG2(a) antibodies are relatively resistant to pepsin, while lgG2(b) and lgG4 do not exhibit such resistance.
lgG antibodies can be made more susceptible to pepsin cleavage by a short preliminary incubation at pH 2.8. A brief digestion afterwards with pepsin is sufficient for full conversion into F(ab)2 fragments.
Alternatively, a longer incubation for 18-24h at 37C, or a brief incubation at an elevated temperature (50min at 70C) can be used to achieve complete digestion of lgG.