Cell line development is a critical step in upstream process development for monoclonal antibodies. Unfortunately, the search for the best-producing clone can be labor- and resource-intensive and is often compared with looking for a needle in a haystack. Cells must first be engineered to produce the biologic of interest and the cell line generated from a high producing clone must deliver a sufficiently high titer to support clinical studies, and ultimately commercialization of the therapeutic.
As a small biotech, you need to move quickly from DNA to material and have the flexibility to address unexpected detours such as a difficult to express antibody which may render the antibody too costly to manufacture and unsuitable for continued investment.
A number of strategies exist to accelerate the timeline from DNA to material and deliver the required titer. Employing the right combination of approaches to create an optimized process requires expertise and experience across all aspects of cell line development.
At early stages, many biotechs turn to a trusted CDMO to guide them through upstream development and to bring the necessary expertise to get it right the first time. Because, if things go wrong, it takes a lot of time and money to redo the work, possibly putting the development program in jeopardy.
Each biotech needs to decide upfront how much risk they are willing to take. BioReliance® End-to-End Solutions is an adaptive CDMO that shares in the risk and implements innovative, custom solutions balancing cost and speed to clinic without sacrificing quality.