Facility

Our Facility Capacity

Equipped with advanced equipment, AskGene Pharma, Inc. is capable of performing molecule screenings, cell line development, small scale upstream/downstream process development, and bioanalysis.  Our business strategy, as of now, is to do the early stage molecule discovery/evaluation and small scale process development in house while also collaborating with CMOs/CROs during the IND enabling stage.  By working closely with CMOs, like Wuxi Biologics and Tmab, our team has successfully filed three biological INDs to China’s FDA and one to EMA.  We are currently undergoing construction of our pilot plant in Nanjing, China, and expect it be completed in 2019.

Molecule Screening/Discovery

AskGene is equipped with FACS, FortéBio Octet RED96, PCRs, and various microplate readers as key assets.  Using this state of the art equipment, we can perform rabbit B cell and mouse hybridoma screenings, antibody variant region sequencing, antibody binding, and functional testing in-house.  We also work closely with reputable CROs to use other technologies such as yeast display, llama nanobody, and computer model based, humanization to increase our chances of finding the best therapeutic candidates.

Cell Line Development

AskGene licensed the GS Chozn CHO cells from SAFC and used it as our platform cell line for production.  With the help of devices such as Clonepix and the CSI imaging system, we can screen the high producer single clone (>2g/L in fed-batch bioreactor mode) in as early as three months.

Upstream/Downstream Process Development

The AskGene upstream team has several small-scale (1L, 7L, 10L) glass bioreactors/fermenters and one Nova Bioflex analyzer, while our downstream team has several AKTA explorers and UF/DF systems.    We heavily apply QbD/DOE strategies for our upstream and downstream process development.  We have delivered processes that have successfully scaled-up to a couple of hundred liters for two of our most advanced projects.

Bioanalysis

AskGene is equipped with most advanced HPLC, CE-SDS, IEF, LC-MS systems, which give us the capacity to characterize our therapeutic candidates extensively and develop/validate assays for lot release.