Use of chromatography in biopharmaceutical production
For chromatography to become a valued tool in biopharmaceutical production the chosen stationary phase must meet exacting standards of efficiency, robustness, flexibility and scalability as best described with a recent real-life example of the production of the peptide pharmaceutical liraglutide by RP-HPLC. Whilst a number of different RP phases with different degrees of hydrophobicity were investigated, the additional flexibility gained from the alkaline stability of YMC-Triart Prep provided additional economic benefits for the method.
These included:
- Additional flexibility of the usable pH range allowed increased solubility of liraglutide and its precursor under alkaline conditions, which contributed to an increase in loadability during process separations.
- Cleaning-in-place (CIP) procedures under alkaline conditions are possible during the process separations.
- The economic viability of the process is maximised because YMC-Triart Prep is based on a perfectly spherical and highly robust hybrid silica particle. This avoids the generation of fines and the subsequent increase in backpressure with the benefit that columns can be packed and unpacked more often without the risk of damaging the phase.
Results
The additional flexibility in terms of pH paid off during the subsequent optimisation steps, as the resolution of the method was best at pH = 8.5. At this pH, a target purity of 99.5%, with a theoretical yield of 71.5% was achieved for pilot-scale chromatography with a 3 mL injection volume.
Seamless scale-up of such results into production was effortless due to the identical chromatographic properties of each particle size of YMC-Triart Prep.
Detailed results, method parameters and information regarding the conducted optimisation steps are available on request.
What can we do for you?
YMC can provide expert support regarding your purification projects. In addition to the development of new methods from scratch, extensive experience is also available for the optimisation of existing processes.
Custom-tailored stationary phases, sampling options, and delivery agreements are just three examples of the manifold possibilities.
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