菜单
Service Overviews

A large quantity of high-quality protein samples are required in antibody drug development and manufacture, such as in vivo pharmacokinetic evaluation, preparation process development and safety evaluation, as well as diagnostic reagent research and production.


Sanyou Bio launches High-quality Bulk Antibody Fast Production Service, which is based on the GMP cell line production. It takes only 35 days to obtain bulk antibody, through construction of stable cell pool for large sample production and further screen of stable high-overexpression cell strain, which aims to constantly produce the protein.

Fig. 5 Binding determination by FACS
Service Overviews A large quantity of high-quality protein samples are required in antibody drug development and manufacture, such as in vivo pharmacokinetic evaluation, preparation process development and safety evaluation, as well as diagnostic reagent research and production. Sanyou Bio launches High-quality Bulk Antibody Fast Production Service, which is based on the GMP cell line production. It takes only 35 days to obtain bulk antibody, through construction of stable cell pool for large sample production and further screen of stable high-overexpression cell strain, which aims to constantly produce the protein. Service Contents Service Service Details Deliverables and Standards Time Rapid preparation of high quality antibody (100 mg) Plasmid containing genes of interest Deliverables: 1. 100 mg of purified antibodies 2. Quality control report Standards: 1. Antibody purity by SDS-PAGE>95%, SEC-HPLC purity >90% 2. Endotoxins<1 EU/mg 3. Affinity (optional): ELISA/FACS/Biacore, depends on the clients’ requirement, within the range of 2 times comparing to the affinity of the control samples 4. Activity (optional): within 2 times comparing to the control samples 4 weeks Rapid preparation of high quality Antibody (500 mg) Plasmid containing genes of interest Deliverables: 1. 375-500 mg of purified antibodies 2. Quality control report Standards: 1. Antibody purity by SDS-PAGE>95%, SEC-HPLC purity>90% 2. Endotoxins<1 EU/mg 3. Affinity (optional): ELISA/FACS/Biacore, depends on the clients’ requirement, within the range of 2 times comparing to the affinity of the control samples 4. Activity (optional): within 2 times comparing to the control samples 5 weeks Rapid preparation of high quality Antibody (1000 mg) Plasmid containing genes of interest Deliverables: 1. 1000 mg of purified antibodies 2 . Quality control report Standards: 1. Antibody purity by SDS-PAGE>95%, SEC-HPLC purity>90% 2. Endotoxins<1 EU/mg 3. Affinity (optional): ELISA/FACS/Biacore, depends on the clients' requirement, within the range of 2 times comparing to the affinity of the control samples 4. Activity (optional): within 2 times comparing to the control samples 5 weeks Service Highlights 1. Quality assurance: Multi-dimensional quality control to ensure high quality Multi-dimensional quality controls including endotoxin, purity, activity, affinity kinetics, thermal stability, and other parameters are applied to ensure antibody quality. 2. Stable mass production: GMP cell line-based stable production Based on GMP cell lines, cell pools stably expressing antibody samples are constructed, and can be stored for long term and are stable for bulk antibody production. 3. Fast:To obtain bulk antibody with only 35 days at the soonest It takes only 35 days from the construction of plasmids to the delivery of bulk antibody. Case Stastics 1. Antibody Yields Analysis As shown in Fig.1, the average expression titer of cell pools from 39 projects is 2.2 g/L and titers of several cell pools are more than 3.0 g/L. Fig. 1 Antibody yields analysis 2. Cell Pool Fed-Batch Culture Fast cell pools are constructed for an antibody of interest. Seven cell pools are selected for fed batch culture in the shake flasks. Growth and metabolism data are collected from the cell pools periodically and the results are shown in Fig. 2. Viable cell density can reach up to 2.5×107 cells/mL, while the cell viability can remain over 70% after 14 days, and the antibody yield is as high as 3.4 g/L. Fig. 2 Cell pool fed-batch culture 3. Antibody Quality Control Analysis 3.1. SDS-PAGE (SDS polyacrylamide gel electrophoresis) Purified antibody of interest is tested by SDS-PAGE, and the result is shown in Fig. 4. The non-reduced and reduced molecular weights are consistent with theoretical molecular weights of the samples and the purities are over 95%, which are compliant with the delivery standards. Fig. 3 SDS-PAGE 3.2. SEC-HPLC (Size exclusion chromatography) Purified antibody of interest is tested by SDS-PAGE, and the result is shown in Fig. 4. The non-reduced and reduced molecular weights are consistent with theoretical molecular weights of the samples and the purities are over 95%, which are compliant with the delivery standards. Fig. 4 SEC-HPLC 4. Antibody Activity Analysis The activity analysis result of the purified antibody A by FACS is shown in Fig. 3. The EC50 is 0.012 μg/mL, indicating that the sample has good biological activity. Fig. 5 Binding determination by FACS

Service Contents

Service

Service Details

Deliverables and Standards

Time

Rapid preparation of high quality antibody (100 mg)

Plasmid containing genes of interest

Deliverables:

1. 100 mg of purified antibodies

2. Quality control report

Standards:

1. Antibody purity by SDS-PAGE>95%, SEC-HPLC purity >90%

2. Endotoxins<1 EU/mg

3. Affinity (optional): ELISA/FACS/Biacore, depends on the clients’ requirement, within the range of 2 times comparing to the affinity of the control samples

4. Activity (optional): within 2 times comparing to the control samples

4 weeks

Rapid preparation of high quality Antibody (500 mg)

Plasmid containing genes of interest

Deliverables:

1. 375-500 mg of purified antibodies

2. Quality control report

Standards:

1. Antibody purity by SDS-PAGE>95%, SEC-HPLC purity>90%

2. Endotoxins<1 EU/mg

3. Affinity (optional): ELISA/FACS/Biacore, depends on the clients’ requirement, within the range of 2 times comparing to the affinity of the control samples

4. Activity (optional): within 2 times comparing to the control samples

5 weeks

Rapid preparation of high quality Antibody (1000 mg)

Plasmid containing genes of interest

Deliverables:

1. 1000 mg of purified antibodies

2 . Quality control report

Standards:

1. Antibody purity by SDS-PAGE>95%, SEC-HPLC purity>90%

2. Endotoxins<1 EU/mg

3. Affinity (optional): ELISA/FACS/Biacore, depends on the clients' requirement, within the range of 2 times comparing to the affinity of the control samples

4. Activity (optional): within 2 times comparing to the control samples

5 weeks


Service Highlights
  • 1. Quality assurance: Multi-dimensional quality control to ensure high quality
    1. Multi-dimensional quality controls including endotoxin, purity, activity, affinity kinetics, thermal stability, and other parameters are applied to ensure antibody quality.
  • 2. Stable mass production: GMP cell line-based stable production
    1. Based on GMP cell lines, cell pools stably expressing antibody samples are constructed, and can be stored for long term and are stable for bulk antibody production.
  • 3. Fast:To obtain bulk antibody with only 35 days at the soonest
    1. It takes only 35 days from the construction of plasmids to the delivery of bulk antibody.

Case Studies
1. Antibody Yields Analysis

As shown in Fig.1, the average expression titer of cell pools from 39 projects is 2.2 g/L and titers of several cell pools are more than 3.0 g/L.


Fig. 1 Antibody yields analysis

2. Cell Pool Fed-Batch Culture
Fast cell pools are constructed for an antibody of interest. Seven cell pools are selected for fed batch culture in the shake flasks. Growth and metabolism data are collected from the cell pools periodically and the results are shown in Fig. 2. Viable cell density can reach up to 2.5×107 cells/mL, while the cell viability can remain over 70% after 14 days, and the antibody yield is as high as 3.4 g/L.


Fig. 2 Cell pool fed-batch culture

3. Antibody Quality Control Analysis

3.1. SDS-PAGE (SDS polyacrylamide gel electrophoresis)

Purified antibody of interest is tested by SDS-PAGE, and the result is shown in Fig. 4. The non-reduced and reduced molecular weights are consistent with theoretical molecular weights of the samples and the purities are over 95%, which are compliant with the delivery standards.


Fig. 3 SDS-PAGE


3.2. SEC-HPLC (Size exclusion chromatography)

Purified antibody of interest is tested by SDS-PAGE, and the result is shown in Fig. 4. The non-reduced and reduced molecular weights are consistent with theoretical molecular weights of the samples and the purities are over 95%, which are compliant with the delivery standards.



Fig. 4 SEC-HPLC

4. Antibody Activity Analysis

The activity analysis result of the purified antibody A by FACS is shown in Fig. 3. The EC50 is 0.012 μg/mL, indicating that the sample has good biological activity.


Fig. 5 Binding determination by FACS