YMC-Triart

In a production process, repeated injections of a solution of insulin in human plasma/serum are carried out. Consequently, absorption of protein and other impurities to the surface of the packing material reduces the retention capacity of the column.

Methodology: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.

Problem:Silica materials are unsuitable for alkaline wash conditions, because of their poor stability at high pH.

Solution: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.

This in turn reduces production costs: Lower consumption of packing material and less downtime due to column repacking. An extension of column lifetime by a factor of > two has been achieved!

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.

With YMC-Triart the output could be increased at the same time as reducing costs.

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.

Challenging Task
The use of 100% water as an eluent has been a challenge in HPLC separation for decades. Even today, many C18 materials suffer from unacceptable short lifetimes, as a result of the C18 chains collapsing which drastically reduces the separation performance. As a pioneer in the field of aqueous compatible phases, YMC has offered suitable products since the 1980’s for stable separations under aqueous conditions.

Solution
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%.