Cell Line Development

Capabilities and Services

Mammalian Cell Line Development 

KBI can apply established mammalian recombinant protein expression systems to provide rapid cell line generation services using:

Both transient expression and stable pool generation approaches are available to support proof-of-concept (POC) material generation for preclinical programs designed to meet the client’s timeline and budgetary objectives.

Cell Line Development Services - KBI Biopharma

SELEXIS CHO-M CLD

Selexis stable cell line development activities are performed as stand-alone services or are fully integrated into larger scope process development programs. Selected cell lines are used for the generation of KBI internal research cell banks (RCBs).

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KBI BIOPHARMA CLD

KBI has additional, complimentary CLD services to meet the development needs of our partners. Both transient expression and stable pool generation approaches are available to support anywhere from proof-of-concept (POC) material generation through full cGMP preclinical programs, designing our approach to meet the client’s timeline and budgetary objectives.

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For full scope process development and cGMP manufacturing programs, the master cell bank (MCB) generation is outsourced to established third-party vendors. KBI conducts the quality audit of a vendor, transfers distribution vials of the selected RCB to the third party facility, manages and provides quality oversight of the pre-bank testing, the MCB production, testing and release under cGMP. Learn more about our manufacturing services.

Microbial Cell Line Development

KBI applies proven, well-characterized, off-the-shelf or engineered microbial recombinant protein expression systems to provide state-of-the-art cell line development. KBI leverages high throughput fermentation and analytical screening tools to rapidly identify the most favorable expression strategy, including tailored approaches based on protein chemistry and structural assessment. Typical expression systems will drive soluble or insoluble protein accumulation in the cytosol, and periplasmic accumulation can be employed in specialized cases depending on the protein of interest. In cases where expression favors insoluble protein accumulation in inclusion bodies (IBs), KBI develops high yielding recovery processes with analytical characterization of conversion to active product by solubilization and refolding procedures.

 

Learn more about KBI Microbial CLD services