Global biologics partner research organization, Abzena will support chemistry, manufacturing, and controls (CMC) of Lipum’s program to develop biologic therapies for the treatment of autoimmune inflammatory diseases.
Einar Pontén, CEO of Lipum, told us that choosing a CMC partner for the project was a critical choice, “Who wants to fly with an airplane at 33,000 ft altitude and find out it was a bad airline? Our careful evaluation led us to Abzena that have a great and committed team that provides the required scientific input, cell line development using their proprietary cell line, as well as the process development.”
Lipum’s 21-month project will work to develop a bile salt-stimulated lipase (BSSL) antibody to inhibit the inflammatory process that occurs with the first possible indication of the drug in juvenile idiopathic arthritis.
Work will take place at Abzena’s sites in Cambridge, UK, and San Diego, US. Joseph Reeds, marketing manager for Abzena told us that at the Cambridge site a research cell bank will be developed using Abzena’s high yielding proprietary CHO cell line.
Additionally, Abzena will support Lipum through the utilization of the Sartorius ambr15, an automated bioreactor system for rapid selection of productive clones.
The CMC partner will also enable Lipum to use automated high throughput bioreactors, generate master cell banks, scale up for process development, and, at the end of the project, it will provide current good manufacturing practice (cGMP) manufacturing for the clinical material.
BSSL protein acts to promote the recruitment of inflammatory and immune cells to the site of acute inflammation, which can then help to control it, but in cases of chronic inflammation, BSSL contributes to continuing it.
Funding the BSSL antibody
The European Commission granted Lipum €2.2m ($2.5m) funding under the EU Framework Program for Research and Technological Development for the purpose of developing its BSSL antibody.
“Lipum was granted €2.2m for our extended pre-clinical work also aiming at an early proof of concept in man and the development of a therapeutic antibody that will provide a novel mode of action in the treatment of chronic inflammatory diseases,” Pontén explained.