- OLIGONUCLEOTIDES : chemical diversity and synthetic issues, delivery and formulation, preclinical studies, clinical updates
- PEPTIDES : manufacturing upstream, purification, drug discovery of the future, alternative applications, drug delivery and formulation, peptides material
Register to attend the conference of Kilian Kobl (Ypso-Facto) : The benefits of mechanistic modeling to characterize and simulate ion exchange oligonucleotide purification processes
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.
Kilian Kobl(a), Lucrèce Nicoud(a), Edouard Nicoud(a), Anna Watson(b), John Andrews(b), Edward Wilkinson(b), Muhid Shahid(b), Chris McKay(c), Benjamin I. Andrews(c), Batool Ahmed Omer(c), Olga Narducci(c), Edward Masson(c)
a Ypso-Facto, 19 Avenue Foch, 54000 Nancy, France
b Chemical Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK
c GlaxoSmithKline, Chemical Development, Gunnels Wood Rd, Stevenage SG1 2NY, UK
Ypso-Facto offers technology enabled-services for chemical and bioprocess development and optimization. We help alleviate some of the complex challenges the (bio)pharmaceutical manufacturing sector is facing today. The pressure is on to reduce the time-to-market and overall cost, while also producing drugs in a more sustainable and environmentally friendly way.
Book a meeting with our team to discuss your challenges and needs : firstname.lastname@example.org