The Frederick, Maryland-based biomanufacturing firm’s StableFast technology generates NS0 cell lines and will be applied to one of Momenta’s biosimilar candidates as part of a deal announced this week.
“We cannot reveal the Momenta development candidate,” BioFactura’s CEO Darryl Sampey told Biopharma-Reporter, but “development stage is preclinical/pre-IND and in the product development pathway.”
Momenta’s most advanced biosimilar candidate is M923, a biosimilar of AbbVie’s Humira (adalimumab), which it is hoping to launch in 2018. It’s second most advanced is a version of Bristol-Myers Squibb’s Orencia (abatacept) and is in the preclinical and process development stages.
The firm also has a number of undisclosed pipeline candidates, including six being co-developed with Mylan following a partnership deal signed in January.
Momenta did not respond to this publication’s request for further information about the deal with BioFactura.
StableFast Platform
The deal gives Momenta the right to obtain an exclusive research and commercial license to StableFast for clinical development and commercial manufacture of the undisclosed.
According to Sampey, the use of his firm’s cell line platform can potentially lower the cost of manufacturing a biosimilar.
“The StableFast Biomanufacturing Platform takes advantage of the NS0 host cell line’s inability to make its own cholesterol which is required for survival,” he said.
“We add the gene that codes for an enzyme that allows the cells to make their own cholesterol along with the genes that code for the drug product. This process results in a manufacturing cell line that can survive in cholesterol-free conditions and that produces high yields of the drug product.”
The cholesterol-free nature of the cell lines allow them to be compatible with single-use technologies which, he continued, plays to the high demand for such systems.
“The requirement of added cholesterol in the legacy NS0 platform causes significant problems in manufacturing both in single-use and classic bioreactors. StableFast eliminates these problems and, additionally, enhances the productivity of the drug product thereby reducing cost of manufacturing.”
Accordingly, over a dozen products have so far been manufactured using StableFast, Sampey added.