菜单
Service Overviews

Sanyou Bio 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 Overviews Sanyou Bio 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 Contents Service Service Details Client Provides Deliverables and Standards Time Production cell line Construction Cell pool Construction Gene sequence 1~5 high-expression cell pools 6-8 weeks Production cell line Construction Monoclonal cell line Construction 3~6 monoclonal cell lines 7-9 weeks Production cell line Construction Cell bank construction (optional) MCB and WCB ≥ 150 vials 4 weeks Production cell line Construction Cell bank inspection (optional) Cell bank inspection records 10~16 weeks (Synergetic stability) Production cell line Construction Cell bank stability study Stability study report 10-16 weeks 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. Case Stastics 1. Cell Line Expression Level Data 1.1. Data summary of cell line construction stage of a monoclonal antibody project The expression level data of cell pool construction and monoclonal cell line construction at various stages of a monoclonal antibody development project ware summarized. As shown in Fig.1, with the same feeding and fermentation conditions, the expression level of monoclonal cell lines increased by 2.4 times compared with that of cell pools. After preliminary optimization, the expression level of monoclonal cell lines in shake flask reached 9.0 g/L. Fig. 1 Data summary of various cell line development stages 1.2. Expression level data of monoclonal cell lines in shake flasks The expression levels of TOP-4 monoclonal cell lines of 10 projects with 14-day feeding and fermentation in shake flasks were analyzed and the results are shown in Fig. 2. As shown in the figure, the expression levels of monoclonal cell lines are between 4 g/L~6 g/L with the highest level reaching 9.0 g/L, indicating that the platform process has been well-established. Fig. 2 Expression level of monoclonal cell lines fed and fermented in shake flasks 2. Data from a Bispecific Antibody Development Project 2.1. Summary of cell line stability data of a bispecific antibody development project In a bispecific antibody development project, cell bank stability study was investigated after development of GMP cell bank. The deviation of gene copy numbers was within 30% and when PDL exceeded 45, the deviation of expression level was within 30%, which met the industry requirements. The cell line is stable enough to support the production at 50, 000-L scale. Fig. 3 Stability evaluation (A. expression level; B. gene copy number) 2.2. Quality analysis data 2.2.1. SEC-HPLC In a bispecific antibody development project, SEC-HPLC was performed on expression products in the shake flask screening stage of cell line development. The results show that the main peak ratio of this bispecific antibody sample is 96.57%. Fig. 4 SEC-HPLC 2.2.2. CE-SDS In a bispecific antibody development project, CE-SDS was performed on expression products in the shake flask screening stage of cell line development. The results show that the main peak ratio of this bispecific antibody sample is 95.4%. Peaks Fig. 5 CE-SDS 2.2.3. CEX In a bispecific antibody development project, CEX was performed on expression products in the shake flask screening stage of cell line development. The results show that the main peak ratio of this bispecific antibody sample is 65.56%. Fig. 6 CEX

Service Contents

Service

Service Details

Client Provides

Deliverables and Standards

Time

Production cell line Construction

Cell pool Construction

Gene sequence

1~5 high-expression cell pools

6-8 weeks

Production cell line Construction

Monoclonal cell line Construction

3~6 monoclonal cell lines

7-9 weeks

Production cell line Construction

Cell bank construction (optional)

MCB and WCB ≥ 150 vials

4 weeks

Production cell line Construction

Cell bank inspection (optional)

Cell bank inspection records

10~16 weeks

(Synergetic stability)

Production cell line Construction

Cell bank stability study

Stability study report

10-16 weeks



Service Highlights
  • 1. High productivity: The expression levels up to 12 g/L
    1. 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
    1. 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
    1. 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
    1. 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
    1. Stable and productive industrial monoclonal cell lines for therapeutic product development can be obtained in approximately 2.5 months.

Case Studies
1. Cell Line Expression Level Data

1.1. Data summary of cell line construction stage of a monoclonal antibody project

The expression level data of cell pool construction and monoclonal cell line construction at various stages of a monoclonal antibody development project ware summarized. As shown in Fig.1, with the same feeding and fermentation conditions, the expression level of monoclonal cell lines increased by 2.4 times compared with that of cell pools. After preliminary optimization, the expression level of monoclonal cell lines in shake flask reached 9.0 g/L.


Fig. 1 Data summary of various cell line development stages


1.2. Expression level data of monoclonal cell lines in shake flasks

The expression levels of TOP-4 monoclonal cell lines of 10 projects with 14-day feeding and fermentation in shake flasks were analyzed and the results are shown in Fig. 2. As shown in the figure, the expression levels of monoclonal cell lines are between 4 g/L-6 g/L with the highest level reaching 9.0 g/L, indicating that the platform process has been well-established.


Fig. 2 Expression level of monoclonal cell lines fed and fermented in shake flasks

2. Data from a Bispecific Antibody Development Project

2.1. Summary of cell line stability data of a bispecific antibody development project

In a bispecific antibody development project, cell bank stability study was investigated after development of GMP cell bank. The deviation of gene copy numbers was within 30% and when PDL exceeded 45, the deviation of expression level was within 30%, which met the industry requirements. The cell line is stable enough to support the production at 50, 000-L scale.


Fig. 3 Stability evaluation (A. expression level; B. gene copy number)


2.2. Quality analysis data

2.2.1. SEC-HPLC

In a bispecific antibody development project, SEC-HPLC was performed on expression products in the shake flask screening stage of cell line development. The results show that the main peak ratio of this bispecific antibody sample is 96.57%.


Fig. 4 SEC-HPLC


2.2.2. CE-SDS

In a bispecific antibody development project, CE-SDS was performed on expression products in the shake flask screening stage of cell line development. The results show that the main peak ratio of this bispecific antibody sample is 95.4%.



Peaks


Fig. 5 CE-SDS


2.2.3. CEX

In a bispecific antibody development project, CEX was performed on expression products in the shake flask screening stage of cell line development. The results show that the main peak ratio of this bispecific antibody sample is 65.56%.


Fig. 6 CEX