Cell Line Development for Antibody Production

We launched a high-expression and stable industrial cell line construction service, aiming to provide global customers with fast, efficient, compliant, high expression, high quality and stable industrial cell lines. 

The platform has introduced 4 sets of commercially authorized cell lines and implemented cGMP standard. It takes only 2.5 months to obtain stable, high-expression, and high-quality cell lines with the expression level reaching up to 12 g/L. Our team members have extensive project experience in the construction and identification of dozens of industrial cell lines, including bispecific antibodies, tri-specific antibodies, monoclonal antibodies and fusion proteins.

Service Highlights

1. High productivity: The expression levels up to 12 g/L

• The production is based on multiple screening systems, such as plate bioreactors, tubular bioreactors, shake flasks, and fermenters. We adopt GS high-expression screening system and provide 4 types of commercially authorized host cells. Bulk pool and mini pool construction modes are used and over 1000 clones are screened to obtain stable high-expression industrial cell lines.

2. Stable production: Over 60 PDL assessments are performed to support commercialized production

• Over 60 PDL assessments concerning cell line passage stability, cellular growth stability, antibody continuous production stability, genetic sequence consistency, and gene copy number are conducted to support commercialized production.

3. Premium quality: Comprehensive quality control and stability evaluations are performed on expression products

• 11 expression product quality control indicators and 10 cell line stability indicators are required. Test results comprehensively guide clone screening to obtain high-quality cell lines.

4. Good compliance: The seed cells conform to cGMP standards and 4 sets of host cells are commercially authorized

• All file records including the host cell traceability, cell line passage records, cell bank construction and verification records are clear and traceable. The monoclonality of cell lines meets the requirements of regulations and the image data were complete. The construction of cell bank conforms to cGMP standards. The verification of cell bank meets the application requirements of China and the United States.

5.  Rapid speed: It takes only 2.5 months to obtain stable and productive monoclonal cell lines

• Stable and productive industrial monoclonal cell lines for therapeutic product development can be obtained in approximately 2.5 months.