Oligonucleotides have emerged as a promising class of pharmaceuticals, leading to a drastically increasing demand. Like peptides, they are typically produced by solid phase synthesis and then purified by reverse-phase chromatography and increasingly ion exchange chromatography. While APIs need to conform to strict purity requirements, most oligonucleotide ion exchange purifications are complex and not fully understood. This is a serious hurdle to reducing process development times, securing scale-up and decreasing waste generation. A digital approach allows overcoming such hurdles by allowing the prediction of the impact of key operating parameters e.g. on yield and purity as well as on raw material and solvent consumptions.
As it is often confounded with adsorption, we explain in this webinar why ion exchange chromatography is fundamentally different from adsorption chromatography. Furthermore, the high charge density and pH-dependent charge of oligonucleotides have prompted the need for developing a new powerful model, which we have implemented in our software Ypso-Ionic®. We present a step-by-step methodology to use this model for your application and illustrate it with real-world examples from AstraZeneca and GSK, leading pharmaceutical companies in the field. This methodology has been shown to lead to significant process understanding with a minimal experimental effort.
In summary, in this webinar, you will discover:
- which benefits you get from simulation and mechanistic modeling for the development of oligonucleotide purification processes,
- an overview of the mechanistic model developed for the needs of oligonucleotide ion exchange,
- how to identify the key experiments necessary for model parameters determination,
- practical examples of applications inspired by leaders in the field.
Keywords : #chromatography #mechanistic #modeling #software #predictive #simulation #purification#oligonucleotide #ionexchange #adsorption