Cell line development (CLD) refers to the processing of a cell line, usually mammalian, that results in the production of a therapeutic biologic or biomolecule. The purpose of CLD is for scientists to tailor cultures to specific desired properties and applications of the targeted product.
A key step in bioprocess development is creating stable cell lines that yield sufficient material for every stage of testing and drug optimization, right up to manufacturing. The methods used by pharma companies during these early project development stages will determine their likelihood of succeeding in developing an effective product in the future.
A basic overview of the cell line development workflow is this:
Gene cloning/initial clone selection
Clone selection and confirmatory analytics
Cultivation/media optimization
Cell line characterization and evaluation
Cell banking
The creation and optimization of cell lines may bring about several problems along the way. But when biopharma companies are aware of the potential challenges they may face, they’re reducing their risk of failure, ensuring their production meets regulatory requirements, and cutting costs associated with having to reuse expensive resources and repeat processes.
How are Cell Lines Developed?
Cell line development companies develop cell lines using five key steps.
First, the desired gene is introduced into a host cell. This is followed by selecting cells that have successfully incorporated the gene.
Then, the selected clones undergo rigorous testing to confirm their gene integration and protein expression, as well as their stability. Scientists identify high-performing clones for further development, and optimal growth conditions are established for this purpose.
The next stage is for scientists to perform comprehensive testing to assess the cell line's performance and safety, and ensure its consistency. The master and working cell banks are then preserved to ensure the long-term stability and reproducibility of the cell line.
What Makes Cell Lines Important?
Developing high-yielding cell lines for testing and manufacturing processes is essential for bioprocess development.
Biopharmaceuticals have the potential to successfully treat a broad range of diseases and disorders, using living host cells as centers for production. So, cell lines play a key role in the development of innovative new drugs and treatments for the population.
What Are the Critical Quality Attributes of Cell Lines?
Some of the critical quality attributes (CQAs) of cell lines include genetic stability and fidelity, identity, viability, and microbiological sterility.
CQAs are also extended to biological activity (including the glycosylation pattern, something that must be closely monitored throughout the development process) and potency when it comes to characterizing the biopharmaceutical product.
Final Word
Cell line development companies play an essential role in the success of the biopharmaceutical industry. The stable and high-performing cell lines produced by these companies can then be used in the creation of therapeutic proteins and other biological products.
Not all companies specializing in CLD are equal, but an experienced company’s expertise is invaluable for accelerating drug discovery and development, ensuring consistently high product quality, and ultimately bringing life-saving therapies to market.
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