Novasep, a provider of purification-based manufacturing solutions for lifescience molecules, has announced that Cerenis Therapeutics has been invited by BioProcess International to present its major project CER – 001 ApoA1 - HDL mimetic drug candidate, and describe how Novasep played a critical role in the project by successfully achieving the transfer and scale up of Apo-A1 production.
CER-001 represents a promising new approach in the fight against atherosclerotic cardiovascular disease. The drug candidate has shown strong preclinical efficacy in promoting reverse lipid transport, a natural cardioprotective mechanism, and excellent safety and tolerability in a phase I study.
Novasep and Cerenis are currently engaged in a global project to improve the manufacturing process of CER-001 and to plan for commercial manufacturing, subject to the approval of the drug. Recently, Novasep and Cerenis were awarded EUR 10.7 million funding from Oseo, a French Governmental agency, to help contribute to the development of CER-001.
Novasep successfully improved the global manufacturing process of CER-001 with improvements of both upstream (USP) and downstream (DSP) process yields. The USP productivity has been substantially increased, after transferring the process previously established. The USP (cell culture) was scaled up using 1000-L disposable bioreactors. Novasep is one of the first companies to implement this technology at that scale. Novasep also tailor made a specific purification process, capitalizing on their recognized expertise in chromatography, resulting in an even more significant improvement in DSP.
“I’ve seen data from big pharma showing up to 17 different purification steps to generate just one per cent of yield,” said Jean-Louis Dasseux, president and CEO of Cerenis. “We can now manufacture these products in just three steps with yields of up to 70 per cent. What we have done with Novasep is game-changing. In my previous company we were never able to produce more than 1kg of the protein; now we can produce multiple batches in multiple kilograms. The yield was also very low because we had batches that constantly failed; now we have batch-to-batch consistency under a GMP process that just wasn’t possible before.”
“The results in the scale up and increase in productivity achieved by Novasep prove the joint commitment of Cerenis’ and our teams to advance this great project,” said Antoine Baule, president of Novasep Process, the bioprocess division of Novasep. “We are delighted that our technologies and expertise in both USP and DSP enabled a robust and highly productive manufacturing process for Cerenis’ recombinant Apoliprotein A-I biopharmaceutical and look forward to take this collaboration to the next step with our important partner Cerenis.”
Novasep is a global provider of cost-effective and sustainable solutions to produce active molecules at the required purity. Novasep’s unique offering includes process development services; purification equipment and turnkey processes; contract manufacturing services; and complex active molecules to serve pharmaceutical; biopharmaceutical; agrochemical; fine chemical; food and functional ingredients; and white biotechnology industries.
Cerenis Therapeutics is a pharmaceutical company focused on the discovery, development and commercialization of breakthrough HDL therapies for the treatment of cardiovascular and metabolic diseases. Based on pioneering research conducted by Cerenis' team of world leaders in HDL therapy, the company is pursuing a range of HDL product candidates that are positioned to represent major advances in patient care and significant commercial opportunities in the treatment of cardiovascular and metabolic diseases. Cerenis has operations in Toulouse, France and Ann Arbor, Michigan.