Cell Line Development
Foundation for Efficient and Scalable Biologics Production
Cell line development (CLD) is a critical step in the development of biologics, shaping the efficiency, yield and quality of therapeutic proteins and antibodies.
Mammalian Cell Lines
- Chinese Hamster Ovary (CHO) cells are the industry gold standard for producing complex glycosylated proteins, including monoclonal antibodies and fusion proteins. Other mammalian hosts include HEK293, NS0 and Sp2/0 cells, selected based on product requirements. These cells are adapted for suspension culture and high-density growth to maximize productivity.
Microbial Cell Lines
- Microbial hosts such as E. coli, Bacillus subtilis and yeasts (Pichia pastoris, Saccharomyces cerevisiae) offer rapid growth and cost-effective production for simpler proteins and enzymes. Anthem supports both microbial and mammalian platforms to provide flexible solutions.
Key Stages in Cell Line Development
Single-Cell Cloning & Stability Assessment
Ensuring monoclonality through advanced cloning techniques and verifying genetic and expression stability over multiple passages to guarantee consistent manufacturing performance.
Screening & Selection
High-throughput screening identifies clones with optimal expression levels, growth characteristics and product quality.
Gene Integration & Transfection
Stable incorporation of the gene of interest into the host genome using random or targeted integration methods, including transposase technology.
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Design of Experiments (DoE) Systematic optimization of culture conditions and expression parameters to enhance yield and quality.
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Genetic Engineering Tools Use of CRISPR/Cas9 and other gene-editing technologies to improve host cell lines for productivity and
product quality. -
Single-Cell Sorting & Imaging Platforms like Beacon® and C.SIGHT™ enable rapid isolation and real-time monitoring of single cells,
accelerating clone selection and reducing timelines.
Monoclonality Assurance
Adherence to regulatory expectations by establishing and documenting monoclonality to ensure product consistency.
Scale-Up Strategies
Seamless transition from lab-scale cultures to commercial bioreactors (up to 30,000 L), maintaining product quality and process robustness.
Regulatory Support
Comprehensive documentation and quality control to support IND, BLA and global regulatory submissions.