2nd Oligonucleotide Manufacturing Symposium event

23 April 2024, Glasgow

• by Ypso-Facto
• March 19, 2024

Ypso-Facto is excited to announce its participation in the 2nd Oligonucleotide Manufacturing Symposium, taking place on April 23, 2024, in Glasgow. 

This symposium will bring together key stakeholders from across the sector to highlight the emerging process technologies in the field and explore how those processes are best developed and exploited to drive successful manufacturing at scale. 

We invite you to join us for a presentation by Kilian Kobl on "The benefits of mechanistic modeling to characterize and simulate ion exchange oligonucleotide purification processes "

Abstract: 

APIs need to meet strict purity requirements. Yet, most oligonucleotide ion exchange purifications are complex and not fully understood. This is a serious hurdle for process development, whether the objective is reducing development times, securing scale-up, or decreasing waste generation. It is often thought that the hurdle can be overcome by performing a DoE and optimizing the process using a mathematical model trained on the DoE data. But, this approach limits the actual understanding of the process itself which remains a black box. 

We present a step-by-step methodology to characterize any ion exchange purification process of multiply charged molecules such as oligonucleotides, peptides, and proteins. This methodology has been developed in collaboration with leading pharmaceutical companies. It has led to significant gains in process understanding with minimal experimental effort, while being adaptable to any application. 

Knowledge gained by the application of the methodology has led to the creation of a new predictive model, which has been added to our modeling software, Ypso-Ionic®. This mechanistic model provides prediction of the impact of key operating parameters, e.g. on yield and purity, as well as on raw materials and solvent consumption. 

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