We make the extraction of active substances even more effective
Active substances are valuable. InstrAction phases increase the yields during purification of low-molecular active substances and proteins for biopharmaceuticals substantially – regardless of the target molecule’s size and solubility. For example, the amount of immunoglobin G extracted from a plasma equivalent is up to 30 per cent higher than when extracted conventionally. If our clients are facing specific problems concerning the separation of the active substance and impurities, it is possible to develop individual multimodal separation phases customized to their needs.
The isolation of IgG from human plasma is one of the biggest chromatographic processes when extracting drug substances of biological origin. When using the instrAction process, it comes to an increase of IgG yields raising from 3.5 to 4.0 g IgG per litre blood plasma extracted with common processes to about 5.2 g IgG extracted with our technology. Our process is based on new types of multimodal chromatographic phases - iChrom® BP1 and iChrom® BP2. In a first step, the combination of the two phases permits the enrichment of IgG of all subtypes – with a simultaneous depletion of serum albumin (ALB) and transferrin on the iChrom® BP1 phase. In a second step, the iChrom® BP2 phase depletes the immunoglobins IgA and IgM below the restrictions of intravenous IgG (IVIG) calculated by the Plasma Protein Therapeutics Association (PPTA). The physiological subclass distribution of immunoglobins IgG1, IgG2, IgG3 and IgG4 does not change during the purification process. The content of product-related IgG impurities like fragments, dimers or aggregates is comparable to or even lower than in other IVIG products. The chromatographic phases iChrom® BP1 and iChrom® BP2 have been developed upon polystyrene-based carrier materials with small and easy available chemical molecules as ligands. This guaranties a high chemical stability (pH 2-14) and sanitization of the phases and through this, the application of common purification protocols (CIP with 1M NaOH) for a packed chromatography matrix.
Classical purification processes for low-molecular and chemically synthetized active substances often include sequences from recrystallizations to achieve the desired purity. By using specific chromatographic phases that are perfectly optimized to bind the target molecule or the impurity, the purification process can be simplified or shortened significantly. During the process of isolation of the active substance Montekulast (a medication against asthma), a classical production sequence consisting of three recrystallization procedures, six fluid/fluid-extractions and one solvent exchange step could be substituted by one single chromatographic step. A chromatographic step on a specific chromatographic phase made by instrAction and without any losses in terms of purity or yields.