How to Develop Large Scale Chromatographic Purification Processes for APIs - a Practical Approach for Process Development and Scale-up

How to Develop Large Scale Chromatographic Purification Processes for APIs – a Practical Approach for Process Development and Scale-up

A well optimized and characterized chromatographic purification process is critical for robust and cost- effective manufacturing. Novasep has accumulated 30 years of experience for streamlining process development of preparative chromatographic processes, based on the successful execution of more than 30 R&D and production projects each year.

In this webinar, we spoke about large scale chromatographic purification processes for APIs from development to scale-up through some typical case studies:

• Purification of complex mixtures coming from natural extract/biomass using semi-continuous and continuous processes (Cyclojet^®, SMB/Varicol^®),
• Implementation of chromatographic resolution of chiral API using continuous processes (SMB/Varicol^®) in the synthesis route of manufacturing of an API including racemization,
• Purification of synthetic complex mixture of API using discontinuous (batch) process

Why you should attend this webinar?

In this webinar, you will learn more about the development & scale-up of chromatographic processes for APIs:

• Which process development strategy should be adopted?
• What are the differences between batch and continuous process scale-up?
• What are key factors to consider in order to implement an efficient chromatography step in your manufacturing process?
• How can preparative chromatography and automation work together?
• What are the throughput and cost benefits in preparative chromatography?

Who should attend this webinar?

• R&D chemists looking to learn how chromatography can be implemented
• Process Engineers working on development/scale up of processes
• Chromatography experts interested to strengthen their knowledge
• Managers/Supervisors (Production/R&D/Industrialization)
• CMC/outsourcing managers

The webinar lasts around 1 hour and was presented by Dr Jin Seok Hur and Jérôme Boni from Novasep, who sponsored the session.

About the Speakers:

Jin Seok Hur, Ph.D.
Technology Director
Novasep, LLC.

Jin Seok Hur received his Ph.D. degree in Chemical Engineering at Purdue University in 2006.  After, he joined Novasep in US as a process development scientist and became the R&D manager in 2008.  From Sep 2011 to Dec 2013, he was leading the team for R&D and cGMP Kilo Lab in Novasep at Pompey, France.  Since he came back to Novasep US in Jan 2014, he has been responsible for the R&D and Technology.

His research interests have been in the area of downstream separation processes, especially, preparative chromatography and membrane.  He has published several technical articles and presented seminars at academic and professional conferences.

Jérôme Boni
Technologies Manager,
Novasep Chasse sur Rhône site

Jérôme Boni is graduated in Organic Chemistry. He joined Novasep in 1999 as R&D Engineer and took several positions as Project Manager, R&D Manager, Production Manager, Industrialization Manager and then Head of R&D and Piloting department (in 2013) at Novasep Pompey site (CDMO & Equipment supplier site).

Since 2017, he has taken the position of Technologies Manager at Novasep Chasse sur Rhône site (near to Lyon, dedicated to manufacturing small molecules/Chemistry), for which he contributes to implement & develop technologies such as Flow chemistry, batch and continuous preparative chromatography, filtration (batch and continuous), ….

His expertise is mainly in the downstream processes field (batch and continuous chromatography using low and high pressure for biomolecules and synthetic, filtration (micro, nano, viral, …) using batch or continuous mode, etc). He also uses modeling and simulation for designing chromatographic processes.

About Novasep:

Novasep provides an extensive range of contract development & manufacturing (CDMO) services to the pharmaceutical industry for both small molecule APIs and biopharmaceuticals. With around 1,500 employees, Novasep is established in Europe, Asia and North America and is constantly expanding its presence to better serve its customers.

Novasep is a world leader in preparative chromatography, with more than 30 years’ experience in commercial manufacturing. Novasep offers a full range of CDMO services with industrial chromatography for purification & chiral separation of APIs, HPAPIs & cGMP intermediates using both batch and continuous HPLC (High Pressure Liquid Chromatography).

As a leading supplier of industrial chromatography equipment (Hipersep®, Varicol®…), Novasep benefits from in-house expertise. A wide range of high-performance automated equipment is installed & dedicated to CDMO activity across 5 of our sites.