Global Bioprocessing Summit & Exhibition
May 10-12, 2023 Berlin (BOOTH 1)
Ypso-Facto will attend the Global Bioprocessing Summit & Exhibition, which will take place from 10-12 May 2023, in Berlin, Germany.
During the event, the world's technology leaders, scientists and engineers from pharma, biotech and pharma suppliers get together for commercial progress and successful large-scale bioprocessing.
Register to attend the conference and talk by Chris McKay - Principal Process Engineer, Chemical Development, GSK on our joint project: Purification by Ion-Exchange Chromatography: Process understanding, modelling and simulation applied to the Oligonucleotide Bepirovirsen
Abstract
Oligonucleotides have emerged as a promising class of pharmaceuticals, leading to a drastically increased demand for their manufacture. Typically produced by solid phase synthesis and then purified by ion exchange or reverse-phase chromatography, solid process understanding is vital to make the most of manufacturing capacity. To achieve an optimized process, many operating parameters need to be investigated to determine their optimal values (e.g. quantity of crude injected, wash duration, gradient slope, pH, flow rate, column dimensions, etc). A typical objective is maximizing yield for a given purity constraint, but also minimizing raw materials consumption and waste generation. Testing all possible combinations experimentally is not always possible due to material costs or human resource constraints, therefore we have investigated the use of predictive mechanistic simulation to aid process optimisation.
In this presentation, we disclose for the first time a cutting-edge mechanistic model describing oligonucleotide purification by ion exchange chromatography. The step-by-step methodology to implement this model is presented and illustrated using the example of Bepirovirsen (GSK3228836), GSK’s investigational antisense oligonucleotide currently being developed for the treatment of chronic hepatitis B. This process modelling methodology has been shown to lead to significant process understanding with a minimal experimental effort.
Kilian Kobla, Lucrèce Nicouda, Edouard Nicouda, Chris McKayb, Ben Andrewsb, Batool Ahmed Omerb, Olga Narduccib, Ed Massonb
a Ypso-Facto, Nancy, France
b GSK, Drug Substance Development, Stevenage UK
Ypso-Facto offers technology enabled-services for 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 : contact@ypso-facto.com
Ypso-Facto is a service company helping industrial firms to develop, optimize and secure their chemical processes and bioprocesses.