Innovative liquid chromatography columns for the pharmaceutical industry that make separation operations faster, more efficient and more sustainable

Project Information

SEP43

Grant agreement ID: 968850

DOI

10.3030/968850

Project closed

EC signature date 27 May 2021

Start date 1 May 2021

End date 30 April 2024

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 3 415 312,50

EU contribution

€ 2 390 718,75

Coordinated by

SEPARATIVE
France

Periodic Reporting for period 2 - SEP43 (Innovative liquid chromatography columns for the pharmaceutical industry that make separation operations faster, more efficient and more sustainable)

Reporting period: 2022-05-01 to 2024-04-30

Summary of the context and overall objectives of the project

After 10 years of R&D, SEPARATIVE’s process replaces the conventional silica column with a micronichoneycomb-structured material to achieve unparalleled performance. Separative has entered in the process automation and control phase. We will explain in this document the progresses made in order to meet the pharmaceutical standards and specifications for a column with 43μm capillaries. We will detail the different tests performed in order to validate that our columns meet the pharmaceutical manufacturing requirements. Our chromatography column, SEP43, is the first to meet the industry need to purify molecules to high purity quickly and at low pressure. Purification is key for all chemical industries and more especially for the pharmaceutical industry. Yet, current techniques are often expensive, slow, energy intensive, and create issues for health, safety and the environment. Hence, purification has become a lock in drug discovery. SEP43 would enable faster drug and chemical development, at lower cost, with a safer and more eco-friendly manufacturing process. On the industrial standpoint, Separative has develop its pilot line specifications, has looked for potential partners/consultants/sub-contractors has validated their technical choices, asked for quotations and has on the automation part passed orders.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

We first demonstrate our ability to reduce the capillary diameter of our columns from 60 to 43 μm.
These monolithic multi-capillary columns evidenced favourable performances meeting theoretical expectations. We have been able to manufacture and test 10 mm diameter columns as expected. We then improved our existing pilot plant thanks to process speeding upby a factor of 20 and quality control tools in order to drive the construction of the industrial one. We have advanced the product and raw material control. All those advances did allow us to reach the first milestone of the project, successful 43 μm industrialisation. The design of the industrial equipment has been carefully studied and ensure a capacity production of 3000 columns during the first year which will rise up to 10 000 columns per year after two years. This industrial equipment has been completely designed by separative, including control strategy and selection of furnishers has been completed. The pilot is today operational.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Beta testing has been conducted on six different sites with reversed phase (C18 grafted) columns. Testing of these columns has shown that the columns are operational for their initial market target, the Flash Chromatography. Increase of performance will open much wider opportunities in the pharmaceutical industries. This includes going one step further in fine tuning the existing pilot. We will then extend this to CDMOs and related companies. This should lead to decreasing the environmental footprint of several purification processes and tend to make API processes greener. And economically sound!

Example of separation

Multicapillary Material

Anne Bouchaudy in a Dissemination Activity