What Is the Cell Line Development Process?
The cell line development process is essential in determining the efficiency of finding new drugs, toxicity, and in-vitro testing. This process reduces cost, effort, and time, which reduces the possibility of drug failure during clinical trials. During the cell line development process, recombinant proteins are produced. These include bi-specific and monoclonal antibodies, vaccines, fusion proteins, enzymes, growth factors, and innovative ways of developing immunotherapies for cancer treatment. At Cell Culture Company, we offer production services for various antibodies, including monoclonal and recombinant, as part of the cell line development process.
Faster Cell Line Development
In an effort to bring down the costs of cell line development, researchers have been pressured to find ways to advance through the early steps of biotherapeutic discovery and candidate selection. Efficiency in this process is achieved through the quick production and selection of cell lines that provide quality recombinant protein in high concentrations, while eliminating clone candidates that are prone to fail as soon as possible.
Cell line development technological advancements have boosted the testing of various drug candidates during the early stages of development, resulting in time and cost efficiencies. Also, companies working on cell line development projects and drug discovery have been collaborating together, resulting in the growth of the cell line development industry.
Cell Line Development Process
The process of cell line development encompasses the following steps:
This is the process of bringing together a foreign DNA with a host cell. When the foreign DNA is incorporated into the genome of a small population of cells that enables them to express recombinant protein over an extended period of time, this group of cells are identified as stably transfected cells.
Antibodies Screening and Titer Ranking
From the transfected pool of cells, a discovery and selection of high-value clones is performed. The chance of discovering a high producer or high affinity-binder is done through screening large populations by quantifying protein-of-interest cell surface expression or secreting antibodies (titer ranking).
Single-cell Isolation and Viability of Cells
In order to ensure the cell population is identical genetically and the heterogeneity of expression is markedly reduced, it is necessary to isolate and clone single, viable cells.
From the perspective of quality and regulatory adherence, it is vital to ensure the cell line is monoclonal, meaning it originates from only one progenitor during the development of cell lines for biotherapeutics. Monoclonality must be documented in the production of therapeutic cell lines as a regulatory requirement, and this is usually an image-based documentation in which recording of a single cell image is taken and added to the regulatory filings.
Clone Productivity Screening and Titer
This test determines the quantity of recombinant antibodies or proteins generated from a cell line derived through cloning.