Name: In Focus: Cell-line development
Uploaded: 2022-12-02T00:00:00.0000000
Duration: T00H03M03S
Description: In Focus: Cell-line development

Name: In Focus: Cell-line development

Description: In Focus: Cell-line development

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Upload Date: 2022-12-02T00:00:00.0000000

Transcript: Language: EN.
Segment:0 .
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BEATRICE BOWLBY: Cell line development is the engineering of a cell line, often mammalian, that produces a desired therapeutic biomolecule, or biologic. Cell line development allows scientists to tailor cultures depending on the research application and the type of biotherapeutic being made, such as monoclonal antibodies or viral vectors. Creating new cell lines can be difficult, so researchers often rely on the modification of an existing cell line to achieve this.
BEATRICE BOWLBY: However, tools are continuously being developed to make cell line development a quicker, easier process. Cell line development involves five key steps. Step one-- gene cloning and transfection. To start, cells of the selected mammalian host cell line are transfected with an engineered expression plasmid encoding for the desired protein. Analysis at this early stage provides insight into the general characteristics of cells carrying the recombinant DNA and their ability to produce the biologic.
BEATRICE BOWLBY: The difficulty here is obtaining multi-parametric data quickly to identify the best clones. Step two-- clone selection and confirmatory analytics. Next, single cells are isolated and expanded to create clonal populations. High-performing clones are stable and capable of producing the desired protein at high titers. The monoclonality of the cell population should also be verified before proceeding to further development.
BEATRICE BOWLBY: At this stage, identifying titer and other critical quality attributes in high throughput can be a challenge. Step three-- cultivation and media optimization. Once screening and clone selection is complete, the best performing clones are expanded. This is when the media and culture conditions are optimized to yield high cell growth. However, this step is difficult to regulate because of inconsistent data analysis and subjective decision making.
BEATRICE BOWLBY: Step four-- cell line evaluation and characterization. This step involves determining the critical quality attributes such as glycosylation profile, stability, and productivity which is used for selecting the lead clones. The lead clones are then fully characterized to ensure that they produce the ideal biologic. This is an important checkpoint, as it informs the cell line's suitability for use in manufacturing the biologic.
BEATRICE BOWLBY: Step five-- cell banking. Finally, lead clones are expanded and a cell bank is generated, ready for characterization and safety testing. However, it is important to bank only the high-quality cells that efficiently produce the biotherapeutic. This helps to produce high yields of the biotherapeutic that will ultimately be used in the patient.
BEATRICE BOWLBY: Each of these five steps comes with its own challenges. But modern tools and custom services provided by companies such as Sartorius are streamlining the cell line development workflow and speeding up timelines. To learn about the latest instrument technologies for cell line development, check out our In Focus with Sartorius on www.biotechniques.com. [MUSIC PLAYING]

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