U.S.-based biologics contract research, development and manufacturing organization (CRDMO), LakePharma, has launched GMP manufacturing of recombinant proteins and antibodies with CHO-GSN and TunaCHO platforms at its Hayward, CA facility.
 
The company said the GMP manufacturing at its Bay Area facility is primarily to support analyte specific reagent (ASR) applications. LakePharma has entered into long-term supply agreements with several commercial clients including some of the top 10 pharma companies.
 
“Separately, we continue to expect the Q3 launch of GMP manufacturing of clinical phase drug substance using the same CHO systems at our Hopkinton, MA facility,” said Minna Rannikko, director of manufacturing solutions, LakePharma.
 
CHO-GSN is LakePharma’s proprietary CHO stable cell line platform, and TunaCHO is LakePharma’s transient CHO platform. The company has previously reported high protein yields—as high as 7 grams per liter and 2 grams per liter, respectively—and robust performance using both platforms.
 
“Using TunaCHO as a transient protein production platform to support GMP commercial product manufacturing is an exciting example of LakePharma’s microBiomanufacturing approach,” said Hua Tu, chief executive officer, LakePharma. “Coupled with LakePharma’s GMP manufacturing of plasmid DNA, the GMP transient production enables LakePharma to rapidly and reliably supply clients with high quality products in the ideal batch range of 10 to 300 grams.”