Manufacturing Biotherapeutics – Starting with CHO Cloning

For every Herceptin, for every Enbrel, Humira and Rituxan, and for every successful biotherapeutic product in the market today, there is a long history of its product development. We all hope that our target protein product will make a difference in both the therapeutic market and the lives it will eventually affect as it reaches its ultimate goal of becoming a human therapeutic. The reality is, in order for it to be a feasible therapeutic, the protein must first be manufactured. And one of the very first steps in determining the manufacturing capability of the product is the crucial step of choosing the production cell line that will produce this protein.

There are many challenges in single cell CHO cloning procedures to obtain valuable stable CHO production cell lines. We often rely on efficient cloning strategies and cloning media to execute such a crucial task in the developmental process of a recombinant protein product. An important aspect of cloning strategies is the cloning media itself. Scientists who dedicate their valuable time and talent in cloning and subcloning potential CHO production cell lines understand the challenges of maintaining viability while promoting cell doubling. Whether cloning in the liquid state or with the aid of a semi solid matrix, the challenges remain the same.

Scientists can combat these challenges by optimizing their cloning media and evaluating which media conditions will sustain high cell viability despite single cell conditions. These same media conditions should also promote adequate cell doubling to facilitate “picking” of clonal populations, with high confidence that the chosen cells are truly clonal. Several media supplements have been successfully used to obtain such an optimized cell cloning media.

You can be working on the next protein that will make a tremendous impact in people’s lives. And when you are faced with the challenges in the early development of this protein, new technologies have made it possible for these challenges to subside.