“…The last parameter to consider when comparing purification processes is productivity. In some cases, MCSGP gives similar results as that of the batch [ 25 ] or slightly lower [ 44 ], but this is only partially a concerning point. Indeed, when dealing with very costly biotherapeutics, it is preferable, from an economic viewpoint, to maximize the recovery of the product rather than productivity of the process.…”
“… Figure 2 Schematic representation of a single switch chromatogram in MCSGP. Reproduced with permissions from [ 44 ]. Figure 3 Schematic representation of the path of the eluent stream during the first switch of an MCSGP cycle.…”
“…This picture shows the elution profiles of the first switch of five MCSGP cycles (these experiments were performed by some of the authors of this review in a former study). The biopharmaceutical of interest in that case was a crude synthetic mixture of a therapeutic peptide (Glucagon) [ 44 ]. As it can be noted, only the first cycle shows a different UV profile with respect to the others, meaning that cycles from 2 to 5 have reached steady-state conditions.…”
“…Lately, some of the authors of this review have successfully investigated the purification of an industrial mixture of Glucagon (29-amino acids peptide) using a 2-column MCSGP equipment. In that case, the yield was 23% higher than the batch, with a purity of nearly 90% [ 44 ].…”
Single-column (batch) preparative chromatography is the technique of choice for purification of biotherapeutics but it is often characterized by an intrinsic limitation in terms of yield-purity trade-off, especially for separations containing a larger number of product-related impurities. This drawback can be alleviated by employing multicolumn continuous chromatography. Among the different methods working in continuous mode, in this paper we will focus in particular on Multicolumn Countercurrent Solvent Gradient Purification (MCSGP) which has been specifically designed for challenging separations of target biomolecules from their product-related impurities. The improvements come from the automatic internal recycling of the impure fractions inside the chromatographic system, which results in an increased yield without compromising the purity of the pool. In this article, steps of the manufacturing process of biopharmaceuticals will be described, as well as the advantages of continuous chromatography over batch processes, by particularly focusing on MCSGP.
“…The last parameter to consider when comparing purification processes is productivity. In some cases, MCSGP gives similar results as that of the batch [ 25 ] or slightly lower [ 44 ], but this is only partially a concerning point. Indeed, when dealing with very costly biotherapeutics, it is preferable, from an economic viewpoint, to maximize the recovery of the product rather than productivity of the process.…”
“… Figure 2 Schematic representation of a single switch chromatogram in MCSGP. Reproduced with permissions from [ 44 ]. Figure 3 Schematic representation of the path of the eluent stream during the first switch of an MCSGP cycle.…”
“…This picture shows the elution profiles of the first switch of five MCSGP cycles (these experiments were performed by some of the authors of this review in a former study). The biopharmaceutical of interest in that case was a crude synthetic mixture of a therapeutic peptide (Glucagon) [ 44 ]. As it can be noted, only the first cycle shows a different UV profile with respect to the others, meaning that cycles from 2 to 5 have reached steady-state conditions.…”
“…Lately, some of the authors of this review have successfully investigated the purification of an industrial mixture of Glucagon (29-amino acids peptide) using a 2-column MCSGP equipment. In that case, the yield was 23% higher than the batch, with a purity of nearly 90% [ 44 ].…”
Single-column (batch) preparative chromatography is the technique of choice for purification of biotherapeutics but it is often characterized by an intrinsic limitation in terms of yield-purity trade-off, especially for separations containing a larger number of product-related impurities. This drawback can be alleviated by employing multicolumn continuous chromatography. Among the different methods working in continuous mode, in this paper we will focus in particular on Multicolumn Countercurrent Solvent Gradient Purification (MCSGP) which has been specifically designed for challenging separations of target biomolecules from their product-related impurities. The improvements come from the automatic internal recycling of the impure fractions inside the chromatographic system, which results in an increased yield without compromising the purity of the pool. In this article, steps of the manufacturing process of biopharmaceuticals will be described, as well as the advantages of continuous chromatography over batch processes, by particularly focusing on MCSGP.
This work reported the application of a twin‐column recycling chromatography system for the separation of three minor impurities in crude aloe‐emodin. The whole process went through three steps, each using a different mobile phase to separate corresponding impurity, which were integrated and automatically operated in a single device. Despite these impurities peaked closely in high‐performance liquid chromatography, they were successfully purified to a content exceeding 97%. In addition, the lab‐scale separation could reach the yields at the mg‐level. The high efficacy should be mainly attributed to the introduction of a small step solvent gradient between the upstream and downstream columns, which helped to counterbalance the band broadening. This report suggested that such an automated chromatographic system could provide fast and accurate separation of multiple impurities, allow the process of high‐throughput samples, and reduce the time required for purification and recovery of minor impurities in drugs.
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