Clinical-grade material to support final preclinical work, IND submission, and Phase I and II clinical trials. The development group deals with incoming projects at initial stages including evaluation of recombinant constructors, yield, efficiency, and characterization of products. This laboratory has the capacity to construct recombinant bacterial strains and cell lines. Both eukaryotic and prokaryotic systems are employed to generate high expression clones which are selected, evaluated and stored under cGMP conditions as Master Cell Banks. The scientific staff has expertise in a variety of fermentation processes including bacterial, yeast, fungi, insect and mammalian cell culture.
Process optimization is the primary focus of the group.
The laboratory currently has 2,000 square feet of laboratory space equipped with PCR, Gel documentation system, column chromatography system, preparative HPLC, environmental shakers, several 20L scale fermentors both researches and process development. 7.5L scale stir tank bioreactors and 80L scale fermentors are in the process of being set up. This group is using and developing novel technologies for the general improvement of yield, efficiency, and quality of biological products. This group can also supply preclinical material for proof of principle in suitable quantities to support studies in animal models, while it's developing optimal, safe, cost effective, scalable, and reliable process for fermentation, recovery, purification, and formulation of the protein. The Production group focuses on implementation of highly efficient bioreactor production utilizing mammalian and microbial fermentation pilot plants with capacity for product recovery.