Abzena, the global biologics gene to GMP partner research organization, announced it has signed an agreement to support an integrated CMC program with Lipum, a company developing treatments for chronic inflammatory diseases.
Abzena will support Lipum’s anti-BSSL antibody IND program to help develop a novel therapeutic option for autoimmune inflammatory diseases, including juvenile idiopathic arthritis. The 18-month program includes: development of a research cell bank using Abzena’s proprietary cell line and ambr® 15 automated high throughput bioreactors, generation of master cell banks, scale up using an ambr® 250 during process development, followed by cGMP manufacturing in Sartorius 500 L single use stirred tank bioreactors for clinical material. The work will take place at Abzena’s sites in Cambridge, UK and San Diego, USA.
Jonathan Goldman, CEO of Abzena, said:
“Autoimmune inflammatory diseases such as juvenile idiopathic arthritis represent significant unmet medical need. We are delighted to leverage our expertise and integrated capabilities to accelerate the timeline to first in man evaluation. Lipum is an innovative science driven organization with visionary leadership and I am personally very excited about the potential for anti-BSSL therapeutics to transform patient outcomes.”
Einar Pontén, CEO of Lipum, said:
“A lead drug candidate has been selected, so this is an exciting step in Lipum’s development. Our antibody is directed towards a novel target protein and will meet a significant medical need. It is essential to have such a competent partner as Abzena. We have a very positive impression of both their resources and staff. It will be stimulating to work with them.”