In a production process, repeated injections of a solution of insulin in human plasma/serum are carried out. Consequently, adsorption of protein and other impurities to the surface of the packing material reduces the retention capacity of the column. At this point a wash step with an alkaline solution (e.g. 0.1 M NaOH) removed the impurities and restores the full capacity of the column.

Hybrid silica based YMC-Triart Prep has an excellent stability at high pH. It is stable to alkaline wash conditions which enables longer column lifetime. A good peak shape is maintained even after 300 alkaline cleaning cycles. This in turn reduces production costs: Lower consumption of packing material and less downtime due to column repacking.

The ability to work with 100% aqueous conditions opens the door to extend the purification range to include polar compounds efficiently and economically. Due to their equivalent selectivity properties, processes can be easily scaled up from analytical to preparative scale.

In addition, desalting can be performed using a RP-C18 phase to reduce one step within the downstream processing. YMC-Triart Prep combines high mechanical strength with chemical stability to ensure robust, long-lasting and economic purifications.

Shearing and crushing of silica particles during repacking of columns leads to the formation of fines which results in increased backpressures. By using mechanically stable, spherical particles the formation of fines can be reduced.

Here, the high mechanical stability of YMC-Triart Prep is demonstrated by means of repeated packing and unpacking of a DAC column. Even after more than 20 repacking cycles for the same material the pressure does not increase. The absence of fines is shown by the constant backpressure. This makes YMC-Triart Prep a valuable phase for method development and especially for process optimisation!

The increasing relevance of peptides creates special demands on the separation methods used. The large variety of peptides with different physico-chemical properties requires suitable stationary phases for purification. Therefore, a selection of different phase modifications for screenings is the best solution. Additionally, the stationary phases used have to be robust, reliable and available in large scale quantities as well as in pre-packed column formats.

With the new YMC-Triart Prep Phenyl-S, YMC offers a new highly stable stationary phase for the preparative purification of peptides. In combination with the existing YMC-Triart Prep phases, the new phenyl-modified stationary phase is an important addition to the existing YMC-Triart family. With this phase, full flexibility for peptide purifications can be achieved.

For this example of the separation of five different peptides, the phenyl-modified YMC-Triart Prep phase leads to the best separation of the critical peak pair. This is the basis for a productive purification process with high loadability.

The efficiency of a preparative purification depends on the selectivity of the stationary phase and its ability to separate possible impurities from the main product. An increase in selectivity would not only improve the degree of separation of the peaks, but also reduce the cleaning costs by increasing the load on the column. Furthermore, the amount of sorbent and consumption of mobile phase could be reduced to increase the yield for a given capacity or to improve the product quality.

Considering the overall costs, the proposed costs to obtain 1 kg insulin (purity ≥ 98.5%, starting from an initial purity 96.5%) with YMC-Triart Prep C8-L and appropriate solvents are 19% lower than with Daisogel SP-120-10-C8-BIO. In terms of process economy YMC Triart Prep C8-L scores the lowest overall purification costs and lowest absolute costs of the stationary phase. The amount of sorbent costs represents only about 1.7% of the overall costs, which is also the lowest percentage of all phases used.

The ability to work with 100% aqueous conditions opens the door to extend the purification range to include polar compounds efficiently and economically. Due to their equivalent selectivity properties, processes can be easily scaled up from analytical to preparative scale.

In addition, desalting can be performed using a RP-C18 phase to reduce one step within the downstream processing. YMC-Triart Prep combines high mechanical strength with chemical stability to ensure robust, long-lasting and economic purifications.

Purification is the most critical step in the manufacturing process of peptide therapeutics. The right choice of chromatography media is crucial for cost-effective production. With its wide pH range (pH 2-10), YMC-Triart Prep C18-S provides you with full flexibility in the method development of peptide purification. Simple scale-up procedures ensure the reproducible result at manufacture-scale. A method for the purification of liraglutide with high resolution (antidiabetic peptide therapeutic, marketed by Novo Nordisk as Victoza^®.) was successfully developed with YMC-Triart Prep C18-S under alkaline condition. The purity obtained for the target compound was 99.5%.