After receiving your approval on a cell line development plan for your project, we can take your gene sequence or cDNA for your recombinant protein or antibody (or from a hybridoma) and engineer a highly productive, stable cell line in CHO, BHK, NS0, HEK-293, or SP2/0 cells or proprietary third-party systems.

After transfection of the cells, screening amplification and subcloning will be performed. The cell lines will use a commercially available media platform that is in a serum-free and chemically defined suspension culture. Upon client request, a stable pool of transfectants can be generated and characterized before the generation of a high-producing single stable clone.

Cell line development activities will typically result in identifying three to five high-producing candidate clones after which a 10-vial frozen cell bank of each will be created.

During the shake flask stage of cell line development, a small-scale, single-column purification step (i.e., protein A) of the harvest can be performed for each cell line for the initial characterization of the protein’s structural characteristics (primary through quaternary) via methods like mass spectrometry, glycosylation, potency, amino acid analysis, binding characteristics, and binding kinetics (Octet systems, Biacore). This will aid in the selection of the optimal cell line along with subsequent generational stability and productivity data.

To ensure the purity and integrity of your product candidate, we offer a panel of qualified assays that expedite product and process development. GBI can also accommodate specific assays transferred from clients and can develop and qualify these assays in accordance with regulatory requirements.

For biologics testing such as viral spiking studies or extended characterizations (e.g., intact mass, drug/chelator-to-antibody mole ratio, peptide mapping) that require equipment such as LC-MS, GBI will work with qualified outside vendors such as contract testing organizations (CTOs).