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.

The ability to use 100% aqueous conditions opens the door to an extended purification range that includes polar compounds efficiently and economically. Still, it is a challenging task: the use of 100% water as an eluent in RP-LC! Even today, many C18 materials suffer from unacceptable short lifetimes, as a result of the C18 chains collapsing which drastically reduces the separation performance.

YMC provided the “original” silica based reversed phase media stable in 100% aqueous conditions. YMC-Triart Prep C18-S continues this 100% aqueous compatibility. Benefit from one of many YMC developments and enjoy boundless freedom for process development.

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.

YMC*Gel is available in a variety of different pore sizes. Pore sizes are usually matched to sample molecule sizes. Pore sizes can also be used to adjust ligand density and hence retention characteristics of a bonded phase, since the size of the pores also affects the total media surface area in a packed column.

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%.