Biologics Process Development
AGC Biologics has extensive experience developing mammalian and microbial production cell lines. This experience, combined with our advanced analytical capabilities, enables us to identify and select clones that meet your product’s specific parameters and characteristics. After selecting the most appropriate clones, we optimize production conditions to develop a high-productivity cell line, tailored to your specific product quality targets and target production level, designed for robust, scalable manufacturing.
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Mammalian
Our mammalian cell line development capabilities include:
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Extensive experience with multiple mammalian cell types and expression systems, including CHO DG44, CHOK1, HEK293, NS0 and PerC6
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Our proprietary CHEF1™ Expression Platform
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Single-cell clone selection based on high titer and quality attributes
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Custom CHO cell line, growth media and production feeds
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Cell line stability analyses
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cGMP cell banking and storage
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Twelve weeks from transfection to clone selection
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Expression of up to 4.5 grams / liter of antibody
The AGC Biologics CHEF1 Expression Platform
This proprietary, robust and scalable expression platform has been used to create many clinical production cell lines. In addition, 5 commercial protein products on the market utilize the CHEF1 Expression platform. The CHEF1 integrated expression platform accelerates the development of cell lines for cGMP production by using robust procedures and chemically defined media and feeds, to produce high levels of recombinant protein in rapid timeframes.
Microbial
Our microbial cell line development capabilities include:
- Demonstrated expertise with E. coli and Pichia microbial expression platforms
- Experience with yeast secretion and E. coli periplasmic secretion, soluble and inclusion body expression
- Cell line stability analyses
- cGMP cell banking and storage services
CLD Recorded Webinar
On-demand webinar: Accelerating Cell Line Development from DNA to Master Cell Bank