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Getting your process up to speed with digital tools; purification of oligonucleotides by ion exchange chromatography
Presented by Kilian Kobl and illustrated with real-world examples from AstraZeneca and GSK
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...
Building a mechanistic model, guidelines and benefits with a focus on enzymatic reactions.
Presented by Yohann Le Guennec and Airy Tilland
Mechanistic models have provided great outcomes for chemical processes development and optimization in the last decades. However, their underlying equations sometimes appear as cryptic for non-initiated people, which limits their acceptance and use. In this webinar, we propose to demystify the development...
Modeling and simulation of ion-exchange in bioprocesses - illustrations from industrial biotech to biopharma
Presented by Yohann Le Guennec
Ion-exchange chromatography is based on the differences in terms of electrostatic interactions of molecules regarding an adsorbent. Nowadays, industrial processes based on ion-exchange chromatography can be found in many different sectors from the food industry for sugars softening, to the biopharmaceutical...
Application of ion-exchange to the purification of multivalent isomers: modeling and simulation
Presented by Lucrèce Nicoud
Ion exchange has been extensively used for many purposes in the medical and pharmaceutical industries over the years. This webinar will present an industrial case study, namely the purification of an amino-glycoside antibiotic produced by fermentation. The mixture to be purified contains two isomers...
Purification of protein by Hydrophobic Interaction Chromatography (HIC): mechanistic modeling for improved understanding and process optimization
Presented by Yohann Le Guennec
Hydrophobic Interaction Chromatography (HIC) is a chromatographic separation technique that is today successfully used for the purification of proteins. However, to achieve highly efficient separations, key operating parameters – like pH and ionic strength – must be well tuned. For this purpose...
Crystallization of polymorphs: advanced process monitoring, data analysis and mechanistic modeling for improved process understanding and optimization
Presented by Lucrèce Nicoud from Ypso-Facto and Richard Becker and Joe Oliva from Blaze Metrics
Many active pharmaceutical ingredients are known to crystallize in different polymorphic forms; a phenomenon that greatly impacts solubility, bioavailability, color, shape, filterability and tabletability. It is key to produce the targeted polymorph at a high purity and with the desired crystal properties...
Associating digital tools and QbD to speed-up process development: a few simple and hopefully rational considerations
By Roger-Marc Nicoud, Ypso-Fcato and Thierry Bastogne, CYBERnano
Regulatory bodies, including the FDA and EMA, are strongly promoting the implementation of QbD: a science and risk-based approach to drug development and manufacturing to increase the success rate, process robustness and eventually product quality. In the meantime, different practitioners are a bit...
Industry 4.0 : Using predictive digital tools to speed-up process development.
A few simple and hopefully rational considerations.
In terms of digitalization, the biotech industries are quite significantly behind others, like the automotive or aeronautical industries, possibly because the digital tools available are not very well suited to their needs. Roger-Marc explains how numerical tools can support process development by...
Deuterium in the 21st century, use in medicinal chemistry and synthetic methods.
Presented by Thomas Jennequin
Ninety years after its discovery, Deuterium is in the spotlights. Since the beginning of the 21 st century, a number of biotechnology companies have successfully explored its potential in drug candidates and generated intellectual property. This approach has been "validated" by the first approval by...
Ypso-Facto is a service company helping industrial firms to develop, optimize and secure their chemical processes and bioprocesses.
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